meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
37
Latest Decision
1995-07-17

Clearances · page 101 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K951473 ULTIMAX Wembley Rubber Products (M) Sdn Bhd KGO Class I 1995-07-17
K952587 ENDOCARE MONOPOLAR ELECTRODES Cytocare, Inc. GEI Class II 1995-07-17
K952299 SURGISCAN SCANNER Norcross Scientific GEX Class II 1995-07-17
K952463 GS & GS20 SURGICAL TOOL SYSTEM Midas Rex Pneumatic Tools, Inc. GET Class I 1995-07-17
K951775 CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) Ceram Optec, Inc. GEX Class II 1995-07-17
K952539 RADIOLOGY PACKS Sterile Concepts, Inc. LRO Class II 1995-07-14
K946362 SILON SILICONE FOAM SHEETING Bio Med Sciences, Inc. MDA Class I 1995-07-13
K953012 DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS Boston Surgical Products, Inc. GFA Class I 1995-07-12
K951714 CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER Cabot Medical Corp. GEX Class II 1995-07-11
K952038 CLEAN-CUFF Instrumed, Inc. KCY Class I 1995-07-11
K951930 CEMENTRALIZER DISTAL STEM CENTRALIZER Depuy, Inc. LZN Class II 1995-07-11
K951905 SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSABLE H.S. Intl. Co., Inc. GEI Class II 1995-07-11
K952678 STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT Avail-Southwest Division KDG Class I 1995-07-10
K943226 BUFFALO FILTER REPLACEMENT FILTER #BSPF030 Buffalo Filter Co., Inc. FYD Class II 1995-07-10
K943227 BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 Buffalo Filter Co., Inc. FYD Class II 1995-07-07
K951812 MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS Lumenis, Inc. GEX Class II 1995-07-07
K931417 STERILE EQUIPMENT COVERS Custom Medical Products, Ltd. MMP Class II 1995-07-06
K951118 3M MAXI-DRIVER II ELECTRIC SYSTEM 3M Company GEY Class I 1995-07-06
K952432 SYMBIOSIS BIPOLAR FORCEPS Symbiosis Corp. GEI Class II 1995-07-05
K952161 BIPOLAR COAGULATION INSTRUMENT Johnson & Johnson Professionals, Inc. GEI Class II 1995-07-05
K941740 ACUFEX ROTATOR CUFF FIXATION BUTTON Acufex Microsurgical, Inc. KGS Class I 1995-06-30
K952598 GX-PAN PANORAMIC DENTAL X-RAY SYSTEM Gendex Corp. GEX Class II 1995-06-29
K952200 OMNI-JUG Waterstone Medical, Inc. KDG Class I 1995-06-29
K952524 AESCULAP BIOPOLAR COAGULATOR Aesculap, Inc. GEI Class II 1995-06-29
K946003 INTEC FULL FACE SHIELD Intec Industries, Inc. LYU Class I 1995-06-28
K950554 NORTH BLOODBORNE PATHOGEN RESPONSE KIT North Safety Products FXX Class II 1995-06-28
K933148 SURGICAL DRAPE KIT Nobelpharma USA, Inc. KKX Class II 1995-06-26
K952323 MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES Mist, Inc. JOS Class II 1995-06-23
K952290 MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES Mist, Inc. JOS Class II 1995-06-23
K952726 ULTRACISION HARMONIC SCAPEL Ultracision, Inc. GEI Class II 1995-06-23
K952543 GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET Neoligaments, Ltd. HWE Class I 1995-06-22
K951911 GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) Commercial Resources New Mexico, Ltd. GDY Class I 1995-06-21
K951854 LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY Leonard Medical, Inc. FQO Class I 1995-06-21
K951166 BIODERM MEDICAL HYDROGEL ISLAND DRESSING Bioderm, Inc. NAE Class I 1995-06-21
K951659 ZOMED MODEL 10 CAUTERY BIOPSY DEVICE Zomed Intl. GEI Class II 1995-06-19
K952632 S-SCORT Sscor BTA Class II 1995-06-16
K950215 ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE Reliant Laser Corp. GEX Class II 1995-06-15
K946271 VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT ETHICON, Inc. GAM Class II 1995-06-15
K951230 MICROSURGE BIPOLAR GRASPERS Microsurge, Inc. GEI Class II 1995-06-14
K951519 WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT Wells Johnson Co. FWL Class I 1995-06-14
K950375 DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR Boston Surgical Products, Inc. GEI Class II 1995-06-14
K952577 ELECTROSURGICAL DISPERSIVE ELECTRODE Medtrex, Inc. GEI Class II 1995-06-14
K951478 GENERAL AND PLASTIC SURGERY PACKS Sterile Concepts, Inc. LRO Class II 1995-06-13
K945688 VALLEYLAB PROCISION(TM) SYSTEM Valleylab, Inc. GEI Class II 1995-06-13
K952340 MEGABEAM ASPIRATING ENDOCULAR PROBE Ceram Optec, Inc. GEX Class II 1995-06-12
K951165 SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEM Sharplan Lasers, Inc. GEX Class II 1995-06-12
K951245 VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORY Vidamed, Inc. GEI Class II 1995-06-09
K946001 EMERGENCY RESPONSE SAFETY KIT Ani Safety, Inc. FXX Class II 1995-06-09
K951420 INCASE EXTENSIBLE BAG--NON-STERILE Alpha Surgical, Inc. LYU Class I 1995-06-08
K946237 ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES Megadyne Medical Products, Inc. GEI Class II 1995-06-07
K945254 ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES Endotec, Inc. GEI Class II 1995-06-06
K946177 VALLEYLAB NS 2000 BIPOLAR GENERATOR SYSTEM Valleylab, Inc. GEI Class II 1995-06-06
K944602 VALLEYLAB FORCE FX Valleylab, Inc. GEI Class II 1995-06-05
K945594 DECA DERMATOME (MICROMOTOR SYSTEM) Depuy Intl., Ltd. GFD Class I 1995-06-05
K951352 DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE Davis & Geck, Inc. GAM Class II 1995-06-05
K933683 PENTAX FACE MASK Pentax Precision Instrument Corp. FXX Class II 1995-06-02
K952162 MEDICAL MIXTURE-LASER GAS MIXTURES Standard Welders Supply Co. GEX Class II 1995-06-01
K945564 MODEL 550-DC CROSSFIRE(TM) Eclipse, Inc. GEX Class II 1995-06-01
K952113 TBN-TIPPED OPTICAL FIBER Myriad Lase, Inc. GEX Class II 1995-06-01
K952301 LASER GAS MIXTURE Airgas Management, Inc. GEX Class II 1995-06-01
K951204 SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR Sharplan Lasers, Inc. GEX Class II 1995-06-01
K951811 OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK Osteotech, Inc. LRP Class I 1995-05-31
K952006 ACCU-BEAM FIBER OPTIC HANDPIECE Tti Medical GEX Class II 1995-05-31
K951324 MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS Maxol Limited L.C. KCZ Class I 1995-05-26
K950831 ALEXLAZR Candela Laser Corp. GEX Class II 1995-05-26
K952300 MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) Midas Rex Pneumatic Tools, Inc. GET Class I 1995-05-26
K951933 UROTEK RE-USABLE FIBEROPTIC CABLE Energy Life Systems Corp. GEX Class II 1995-05-26
K950311 GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE Global Medical Products, Ltd. GDF Class I 1995-05-26
K952204 CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADES Conmedcorp GEI Class II 1995-05-25
K945755 OREX(R) O.R EQUIPMENT DRAPES Thantex Specialties, Inc. KKX Class II 1995-05-25
K951732 NEZHAT-DORESEY PENCIL-GRIP HANDLES American Hydro-Surgical Instruments, Inc. GEI Class II 1995-05-24
K926496 SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN Sil-Med Corp. GBX Class I 1995-05-24
K951985 PRECISION BIPOLAR COAGULATOR Valley Forge Scientific Corp. GEI Class II 1995-05-23
K944937 SYNTHETIC ABSORBABLE SUTURE Johnson & Johnson International GAM Class II 1995-05-19
K951064 DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC S-E Sales & Distribution, Inc. FTY Class I 1995-05-19
K935525 PHOTOTHERAPEUTIX MODEL 2480AB Avex Industries , Ltd. FTC Class II 1995-05-19
K940615 ACCUTEST Instrumed, Inc. KCY Class I 1995-05-19
K951661 PROFEEL Wembley Rubber Products (M) Sdn Bhd KGO Class I 1995-05-17
K950663 BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR Bei Medical Systems Co., Inc. GEI Class II 1995-05-17
K951450 SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY Strenumed, Inc. KIJ Class I 1995-05-17
K951662 COMFIT/BEADED SURGEON'S GLOVE Wembley Rubber Products (M) Sdn Bhd KGO Class I 1995-05-17
K942351 DI ISOLATION GOWN Derekduck Industries Corp. FYC Class II 1995-05-17
K950455 DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES Aaron Medical Industries JOS Class II 1995-05-16
K933077 EXETER INTRAMEDULLARY BONE PLUG Howmedica Corp. LZN Class II 1995-05-16
K951860 HOWMEDICE BONE PLUG Howmedica Corp. LZN Class II 1995-05-16
K951731 NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS American Hydro-Surgical Instruments, Inc. GEI Class II 1995-05-16
K951214 STERILE EQUIPMENT COVER Gulfstream Medical KKX Class II 1995-05-16
K951934 PFC CEMENT RESTRICTOR Johnson & Johnson Professionals, Inc. LZN Class II 1995-05-16
K951326 BIOPSY DEVICE ACCESSORY Biopsys Medical, Inc. BTA Class II 1995-05-15
K951907 NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER Navarre Biomedical , Ltd. GBX Class I 1995-05-15
K945614 ADD POWER FAMILY , MICRO ADDSTAT Laserscope GEX Class II 1995-05-15
K951085 PADGETT AIR DERMATOME, MODEL A Padgett Instruments, Inc. GFD Class I 1995-05-15
K951912 DISOPOSABLE & RESUABLE MONPOLAR CORD Boston Surgical Products, Inc. GEI Class II 1995-05-12
K944590 ETHICON DRILL BIT AND DRILL GUIDE ETHICON, Inc. HSZ Class I 1995-05-11
K943727 BIOSTOP G BONE CEMENT RESTRICTOR Landos, Inc. LZN Class II 1995-05-11
K951803 ROSSITER SINUS STENT Smith & Nephew Richards, Inc. KAM Class I 1995-05-11
K941845 BUSE STAFF PROTECTION GOWNS AND KITS Busse Hospital Disposables, Inc. FYC Class II 1995-05-10
K950698 LSU 2000 PORTABLE SUCTION UNIT Laerdal Medical Corp. JCX Class II 1995-05-09
K950495 SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 Surgical Dynamics, Inc. BTA Class II 1995-05-09
K944265 NEEDLE ELCTRODE Unimed Surgical Products, Inc. GEI Class II 1995-05-05

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.