meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
43
Latest Decision
1993-07-26

Clearances · page 112 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K933017 MODEL 5030 SUCTION HANDPIECE SYSTEM Sunrise Technologies, Inc. GEX Class II 1993-07-26
K931306 ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT Cardiogenes GEX Class II 1993-07-23
K924881 REFLEX(R) ESP Richard-Allan Medical GEI Class II 1993-07-23
K932725 B-D ULTRA FINE(R) LANCET Bd Becton Dickinson Vacutainer Systems Preanalytic FMK Class II 1993-07-23
K931480 CLEANBLADE Cleanblade, Inc. GEI Class II 1993-07-23
K925290 CATALOG NUMBER 111 (FACESHIELD) Ansley Medical Products, Inc. LYU Class I 1993-07-23
K930900 COOK ASPIRATION UNIT Cook Ob/Gyn JCX Class II 1993-07-22
K932065 DLASE 300 UPGRADE Incirt Tech., Inc. GEX Class II 1993-07-22
K930568 ADAIR/VERESS NEEDLE INTRODUCER SET Medical Dynamics, Inc. GCB Class I 1993-07-22
K930439 MARCO SURGISCOPE OPERATION MICROSCOPES Marco Ophthalmic, Inc. HRM Class I 1993-07-22
K931774 UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER Sunrise Technologies, Inc. GEX Class II 1993-07-22
K932112 OLYMPIC INFA-LENGTH Olympic Medical Corp. FTY Class I 1993-07-22
K926547 MEDNEXT 1000 BONE DISSECTING SYSTEM Mednext, Inc. HSZ Class I 1993-07-22
K926224 DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS Diomedics, Inc. GEX Class II 1993-07-22
K924929 REFLEX(R) ECA Richard-Allan Medical HBT Class I 1993-07-21
K931379 MICROVASIVE INSURG LAPTIE SUTURE LIGATOR Boston Scientific Corp HCF Class I 1993-07-13
K925030 SURGEON'S GLOVE Wuhrlin Soplamed (M) Sdn Bhd KGO Class I 1993-07-13
K926217 TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE Terumo Medical Corp. GBZ Class I 1993-07-13
K926508 INTRASITE GEL Smith & Nephew United, Inc. NAE Class I 1993-07-13
K924213 ECLIPSE 2100(TM), MODIFICATION Elipse Surgical Technologies, Inc. GEX Class II 1993-07-13
K923840 NEEDLE-GRABBER Guardian Angel Products, Inc. GDF Class I 1993-07-13
K925628 ULTRATUFF CUT RESISTANT GLOVE LINER Baxter Healthcare Corp LYU Class I 1993-07-09
K930700 MEDLINES REPEAT PERFORMANCE SURGICAL PACK SYSTEM Medline Industries, Inc. LRO Class II 1993-07-09
K921157 O.R./SURGEONS GOWN, ITEM NO. 4942 The Sewing Source, Inc. FYA Class II 1993-07-09
K923835 THE ELEVENTH FINGER Guardian Angel Products, Inc. GDF Class I 1993-07-09
K921152 O.R./SURGEONS GOWN, ITEM NO. 4952 The Sewing Source, Inc. FYA Class II 1993-07-09
K921153 O.R./SURGEONS GOWN, ITEM NO. 4960 The Sewing Source, Inc. FYA Class II 1993-07-09
K921158 O.R./SURGEONS GOWN, ITEM NO. 4950 The Sewing Source, Inc. FYA Class II 1993-07-09
K932219 SUTURE SET OR LACERATION TRAYS (PACKS) Associated Medical Products Co. KDD Class I 1993-07-09
K921156 O.R./SURGEONS GOWN, ITEM NO.4941 The Sewing Source, Inc. FYA Class II 1993-07-09
K921155 O.R./SURGEONS GOWN, ITEM NO. 4962 The Sewing Source, Inc. FYA Class II 1993-07-09
K924468 STERILE INSTRUMENT TRAYS/BASIN SETS Baxter Healthcare Corp LRO Class II 1993-07-09
K921154 O.R./SURGEONS GOWN, ITEM NO. 4962 The Sewing Source, Inc. FYA Class II 1993-07-09
K921151 O.R./SURGEONS GOWN, ITEM NO. 4951 The Sewing Source, Inc. FYA Class II 1993-07-09
K924588 ZEISS LASER INDIRECT OPHTHALMOSCOPE Carl Zeiss, Inc. GEX Class II 1993-07-09
K926566 CARE-E-VAC Aeros Instruments, Inc. BTA Class II 1993-07-09
K925815 REUSABLE LIQUIDPROOF BOOTIE Amsco Sterile Recoveries, Inc. FXP Class I 1993-07-09
K931056 DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING American Cyanamid Co. GDW Class II 1993-07-08
K931063 THE ELITE EPILATOR Instantron KCW Class I 1993-07-08
K931064 THE BLENDTONE EPILATOR Instantron KCW Class I 1993-07-08
K931062 THE VP500 EPILATOR Instantron KCW Class I 1993-07-08
K931933 CHAD LABS ADHESIVE BANDAGE REMOVER Chad Labs Corp. KOX Class I 1993-07-08
K926143 ANGIOLAPCATH CHOLANGIOGRAPHY KIT Bd Becton Dickinson Vacutainer Systems Preanalytic GBZ Class I 1993-07-07
K924212 STRYKER ENDOSCOPY CHOLANGIOGRAM KIT Stryker Corp. GBZ Class I 1993-07-07
K930160 ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE Symbiosis Corp. GDM Class I 1993-07-06
K922918 BARRIER SAF-TE HYDROGEL DRAPE Johnson & Johnson International KKX Class II 1993-07-06
K925214 SHAVE PREP TRAYS (NON-STERILE) American Healthcare Supply Co., Inc. LRO Class II 1993-07-02
K930158 BONE MARROW BIOPSY PROCEDURE TRAY Symbiosis Corp. GAA Class I 1993-07-02
K921019 HARGIS RECTAL SELF RETRATION SYSTEM Medin Corp. GAD Class I 1993-07-02
K921017 HARGIS SR2 SELF-RETRACTION SYSTEM Medin Corp. GAD Class I 1993-07-02
K925908 AP01 AND AP02 Surgical Laser Technologies, Inc. GEX Class II 1993-07-02
K921020 HARGIS SELF RETRACTION SYSTEM Medin Corp. GAD Class I 1993-07-02
K921271 ELECTROSURGICAL UNIT E & M Engineering, Inc. GEI Class II 1993-07-02
K930497 ARGON HANDPIECES Beacon Laboratories, Inc. GEI Class II 1993-06-25
K925840 ECLIPSE 3200 Cardiogenes GEX Class II 1993-06-25
K931303 WOODLYN OPERATION MICROSCOPE Woodlyn, Inc. FSO Class I 1993-06-25
K930897 MI-15 EXAM SURGICAL LIGHT Medical Illumination, Inc. FTD Class II 1993-06-25
K931051 MODEL 110 ND:YAG LASER Excel Tech. , Ltd. GEX Class II 1993-06-25
K924410 LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION Core Dynamics, Inc. GEI Class II 1993-06-25
K931610 OMNISORB II, NONWOVEN SPONGE, STERILE AND NON Omni Mfg., Inc. NAB Class I 1993-06-24
K925526 MANIPLER DISPOSABLE SKIN STAPLER Matsutani Seisakusho Co. , Ltd. GDT Class I 1993-06-24
K930697 MEDLINE STERILE GAUZE SPONGES Medline Industries, Inc. NAD Class I 1993-06-24
K930543 E-25 KRYPTON ION LASER (SURGICA K5) Hgm, Inc. GEX Class II 1993-06-22
K930493 QUANTUM 3080 SURGICAL TABLE American Sterilizer Co. FQO Class I 1993-06-22
K926513 MOLLER-WEDEL OPERATING MICROSCOPE Moeller Microsurgical, Inc. FSO Class I 1993-06-22
K925216 STERILE SKIN SCRUB TRAYS American Healthcare Supply Co., Inc. LRO Class II 1993-06-22
K914037 MEDSURG O.R. PROCEDURE TRAY Medsurg Industries, Inc. LRO Class II 1993-06-22
K924028 LAPAROSCOPIC SURGICAL INSTRUMENT Jana Medical GEI Class II 1993-06-18
K930549 LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000 Rustronics, Inc. BTA Class II 1993-06-18
K923176 SURGICAL INSTRUMENT KIT, DISPOSABLE Ulti-Med Intl., Inc. KDD Class I 1993-06-17
K925984 ACUCISE ELECTROSURGICAL TROCAR Applied Medical Resources GEI Class II 1993-06-17
K925905 KIT, SURGICAL INSTRUMENT, DISPOSABLE Kay Medical Concepts KDD Class I 1993-06-16
K922407 WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS Wells Lamont Corp. LYU Class I 1993-06-15
K925883 OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS Osteonics Corp. JDJ Class II 1993-06-15
K932003 N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN) National Healthcare Linen Service FYA Class II 1993-06-11
K922576 AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS Aesculap, Inc. GEI Class II 1993-06-10
K930355 MICROSURGE SUCTION/IRRIGATION SYSTEM CANNULAS Microsurge, Inc. GEI Class II 1993-06-08
K926109 FLUID DRAINAGE TRAY Symbiosis Corp. GBX Class I 1993-06-07
K924958 BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY Medical Insights, Inc. KDD Class I 1993-06-07
K922133 HOSPITAL KIT SV 105 Savoy Medical Supply Co., Inc. LRO Class II 1993-06-07
K925015 STERILE SUTURE REMOVAL KIT Customed, Inc. MCZ Class I 1993-06-07
K924647 DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST Derma-Lase Co. GEX Class II 1993-06-04
K926166 COAST VIDEO ENDOSCOPIC IMAGING SYSTEM Optik FWF Class I 1993-06-01
K925215 STERILE SURGICAL INSTRUMENT TRAYS American Healthcare Supply Co., Inc. KDD Class I 1993-06-01
K932186 BYPASS LEG POSITIONER Voss Medical Products FQO Class I 1993-06-01
K925742 CLARUS CHOLANGIOGRAM CATHETER KIT Clarus Medical Systems, Inc. GBZ Class I 1993-06-01
K925707 INSTRUMENT, MANUAL, GENERAL SURGICAL Symbiosis Corp. GEI Class II 1993-05-26
K922130 HOSPITAL KIT DK 117 Savoy Medical Supply Co., Inc. MDM Class I 1993-05-24
K930789 8-WATT PULSED DENTAL LASER SYSTEM Sunrise Technologies, Inc. GEX Class II 1993-05-21
K930879 2.5 WATT PULSED DENTAL LASER SYSTEM Sunrise Technologies, Inc. GEX Class II 1993-05-21
K925395 TECHNOMED PULSOLITH 4000 LASER SYSTEM Teknomed, Inc. LNK Class II 1993-05-21
K924917 HARMONIC SCALPEL 5MM LAPAROSONIC BLADE ACCESSORY Ultracision, Inc. GEI Class II 1993-05-21
K925851 COOK TISSUE MORCELLATOR Cook Urological, Inc. GEI Class II 1993-05-21
K925024 ORC TAPPERED IRRIGATING PROBE O.R. Concepts, Inc. GCY Class I 1993-05-21
K925145 TRACE MODEL #'S 840, 841, 842, 845 Trace Medical Equipment, Inc. FYH Class I 1993-05-19
K926126 SUTUREMATE Surgical Safety Products, Inc. MDM Class I 1993-05-19
K925870 SPACER Bip USA, Inc. MJG Class I 1993-05-19
K922902 SALMAN SINUS BUTTON Boston Medical Products, Inc. KAM Class I 1993-05-18
K926414 VALLEYLAB MACROBIPOLAR FORCEPS HANDPIECE, E3200 Valleylab, Inc. GEI Class II 1993-05-17
K923599 OPTILITE FIBEROPTIC DELIVERY SYSTEMS Xintec Corporation GEX Class II 1993-05-17

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