meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
45
Latest Decision
1994-02-17

Clearances · page 109 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K934985 ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD KARL STORZ Endoscopy-America, Inc. GEI Class II 1994-02-17
K934656 CONMED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUNDING PADS Conmedcorp GEI Class II 1994-02-17
K934800 CONMED SELECTONE SURGICAL INSTRUMENTS Conmedcorp GEI Class II 1994-02-17
K935457 LOCALIZATION WIRE OR MARKER - SURGICAL Bip USA, Inc. GDF Class I 1994-02-17
K934028 STERILE DRESSING CHANGE TRAY Surgipro, Inc. LRO Class II 1994-02-17
K914715 PARALLELING GUIDES Implant Corp. of America FZX Class I 1994-02-16
K935741 O.R. BASIN SET TRAY Cush Medical Products LRO Class II 1994-02-15
K935848 BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING Brady Medical Products Co. NAE Class I 1994-02-15
K920978 ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED ETHICON, Inc. GAN Class II 1994-02-15
K934601 NDM HYDROGAUZE WOUND DRESSING Ndm Acquisition Corp. NAE Class I 1994-02-15
K933131 BISTAT 70/70-I ELECTROSURGICAL UNIT Medical and Scientific Enterprises, Inc. GEI Class II 1994-02-15
K935705 ALLEVYN ISLAND WOUND DRESSING Smith & Nephew United, Inc. NAE Class I 1994-02-15
K934682 SURGICAL VIDEO CAMERA AND ACCESSORIES Medical Dynamics, Inc. FWF Class I 1994-02-15
K933364 PROMED BIOPSY NEEDLE Vlv Associates, Inc. DWO Class I 1994-02-15
K935098 BABY BOARD Sentry Medical Products, Inc. BTX Class I 1994-02-15
K931094 PROCEL(TM) DERMALINER GLOVE W. L. Gore & Associates, Inc. LYU Class I 1994-02-14
K926481 VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET Valleylab, Inc. GEI Class II 1994-02-12
K931258 SOFTTOUCH II LANCET DEVICE Boehringer Mannheim Corp. FMK Class II 1994-02-10
K930316 LUNG RETRACTORS: DAVIDSON, SEMB Thomasville Medical Assoc. GAD Class I 1994-02-10
K920108 BARRIER EXTRA PROTECTION PLUS FACE MASK Johnson & Johnson Medical, Inc. FXX Class II 1994-02-10
K930681 3M PREVENTION FABRIC SURGICAL GOWN #78XX 3M Health Care, Ltd. FYA Class II 1994-02-10
K935499 PMT SILICONE SHEETING Pmt Corp. MDA Class I 1994-02-10
K933016 CANDELA PLTL-1 LASER SYSTEM Candela Laser Corp. GEX Class II 1994-02-09
K935483 E-Z PREP(R) TRAY WITH HIBICLENS(R) Bd Becton Dickinson Vacutainer Systems Preanalytic LRO Class II 1994-02-09
K930043 ACU-EVAC Acuderm, Inc. FYD Class II 1994-02-09
K920218 ESOPHAGEAL Z-STENT Wilson-Cook Medical, Inc. ESW Class II 1994-02-09
K935010 WALLACH ULTRA FREEZE Wallach Surgical Devices, Inc. GEH Class II 1994-02-09
K934215 CONTAIN-OR Dlp, Inc. KKX Class II 1994-02-09
K932336 NU-GEL ISLAND WOUND DRESSING Johnson & Johnson Medical, Inc. NAE Class I 1994-02-09
K931546 END-IRRIGATING ENDOILLUMINATOR Infinitech, Inc. FST Class II 1994-02-09
K931820 CARAPACE STILLWATER BOWL SET Carapace, Inc. LRO Class II 1994-02-07
K934971 STERILE LAPAROTOMY SPONGES Medsurg Industries, Inc. GDY Class I 1994-02-07
K935441 INFINITECH BREATH EZ Infinitech, Inc. BWN Class I 1994-02-07
K931760 CARAPACE PACKING GAUZE TRAYS Carapace, Inc. LRO Class II 1994-02-04
K925861 GIMBEL PUNCTURE RESISTANT SURGICAL GLOVE Gimbel Glove Co. KGO Class I 1994-02-04
K934029 STERILE LACERATION & DEBRIDEMENT TRAYS Surgipro, Inc. LRO Class II 1994-02-04
K930315 THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE Thomasville Medical Assoc. GDJ Class I 1994-02-04
K934389 UROTEK LASER CATHETER Energy Life Systems Corp. GEX Class II 1994-02-03
K932253 ARTHROBOT BI-FOLD DRAPE Andronic Devices, Ltd. KKX Class II 1994-02-03
K930794 MEDIGLOVES, MEDPAC, BOSTON, FISHERBRAND, GLOVES Medigloves , Ltd. KGO Class I 1994-02-03
K935803 CICA-CARE SILICONE GEL SHEET Smith & Nephew United, Inc. MDA Class I 1994-02-03
K936210 NPAC National Healthcare Linen Service KKX Class II 1994-02-03
K925185 ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS Louis M. Gerson Co., Inc. FXX Class II 1994-02-03
K931091 DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252 Alliance Medical, Inc. KKX Class II 1994-02-03
K935883 NEUROLOGICAL SPONGES Mcneil Healthcare, Inc. GDY Class I 1994-02-03
K932723 CONBIO CUB-D10 COPPER LASER SYSTEM Buckman Co., Inc. GEX Class II 1994-02-03
K934233 ZARA ZONE IV MALAR IMPLANT MODIFICATION Byron Medical LZK Class II 1994-02-03
K934089 BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S Bio Quantum Technologies, Inc. GEX Class II 1994-02-03
K934829 HASKON MEDICAL GRADE SHEETING Haskon Intl., Inc. MDA Class I 1994-02-03
K925850 DISPOSABLE UNIVERSAL LAPORASCOPIC SCISSORS H.S. Intl. Co., Inc. GEI Class II 1994-02-03
K935993 SURGICAL SPONGE X-RAY DETECTABLE Mcneil Healthcare, Inc. GDY Class I 1994-02-02
K926408 SIL-SLIP FLAT SUCTION DRAIN Sil-Med Corp. GBX Class I 1994-02-02
K926495 SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE Sil-Med Corp. GBX Class I 1994-02-02
K935779 AGAFAR FACE SHIELD Infection Control Products, Inc. LYU Class I 1994-02-01
K935910 X-RAY PACKING SPONGE Mcneil Healthcare, Inc. GDY Class I 1994-01-31
K933062 B-D(R) CHALLENGE POWDER FREE SYNTHETIC SURG GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic KGO Class I 1994-01-31
K935881 SPECIALTY SPONGES Mcneil Healthcare, Inc. GDY Class I 1994-01-31
K935882 TONSIL SPONGES Mcneil Healthcare, Inc. GDY Class I 1994-01-31
K930822 GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH W. L. Gore & Associates, Inc. FTL Class II 1994-01-28
K935322 SNAP BONE REAMER Surgiquip, Inc. HWE Class I 1994-01-28
K931395 SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM Micro Surgical Instruments Corp. KIJ Class I 1994-01-28
K935357 SNAP RECIPROCATING SAW Surgiquip, Inc. GAF Class I 1994-01-28
K932391 NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET Navarre Biomedical , Ltd. GBX Class I 1994-01-27
K934431 PNEUMATIC WIRE TENSIONER Smith & Nephew Richards, Inc. HSZ Class I 1994-01-27
K931540 UNIVERSAL BONE CEMENT KIT Biodynamic Technologies, Inc. LZN Class II 1994-01-27
K931769 SNAP OSCILLATING SAW Surgiquip, Inc. GFA Class I 1994-01-27
K935516 SNAP DRILL Surgiquip, Inc. HWE Class I 1994-01-27
K933382 IMC CABLE/WIRE COVER Inman Medical Corp. KKX Class II 1994-01-27
K933699 GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS Geister Medizin Technik GmbH GEI Class II 1994-01-27
K934390 OSCILLATING BONE SAW BLADE, 6200 SERIES Boehringer Laboratories GFA Class I 1994-01-26
K931758 CARAPACE WOUND DRESSING KITS & LACERATION TRAYS Carapace, Inc. LRO Class II 1994-01-26
K920292 VARIOUS KITS AND TRAYS Professional Medical Products, Inc. LRO Class II 1994-01-26
K931176 BONE SAW BLADES Betzler Mfg., Inc. HWE Class I 1994-01-26
K934030 STERILE TRACHEOSTOMY TRAY Surgipro, Inc. LRO Class II 1994-01-26
K934583 BURRS American Medical Specialties, Inc. GFF Class I 1994-01-26
K932699 ARTHREX AR-8200 SHAVER SYSTEM Arthrex, Inc. HWE Class I 1994-01-25
K931759 CARAPACE STERILE GAUZE TRAYS Carapace, Inc. LRO Class II 1994-01-25
K931844 CUSTOM PROCEDURE MEDICAL TRAY OR KIT Custom Medical Products, Ltd. LRO Class II 1994-01-25
K935854 ULTRAVIOLET LAMPS FOR TANNING Cosmedico Light, Inc. LEJ Class II 1994-01-24
K931288 ISOLAIR 2 FULL FACE SPLASH GUARD Louis M. Gerson Co., Inc. LYU Class I 1994-01-21
K935567 SODEM POWER SYSTEM Sodemsystems HWE Class I 1994-01-21
K935258 HYBRID SURGICAL DEVICE MODIFICATION Lca, Inc. GEX Class II 1994-01-13
K934427 PILLING LAPAROSCOPIC INSTRUMENTATION Pilling Co. GEI Class II 1994-01-10
K933007 SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS Sunrise Technologies, Inc. GEX Class II 1994-01-10
K931936 GIANTURCO-HELFRICH HERNIS MESH Cook, Inc. FTL Class II 1994-01-10
K934092 CAMERA, SURGICAL AND ACCESSORIES Envision Medical Corp. FWB Class I 1994-01-07
K932513 LABELING FOR MYO/WIRE II STERNOTOMY SUTURES Alto Development Corp. GAO Class II 1994-01-07
K931837 ACUFEX STERILE DRILLS Acufex Microsurgical, Inc. HWE Class I 1994-01-07
K932493 SURGICAL CURETTE Whitney Products, Inc. FZS Class I 1994-01-07
K930826 SUTURE NONABSORBABLE - SILK Surgical Specialties, Inc. GAP Class II 1994-01-07
K931271 ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE ETHICON, Inc. GAQ Class II 1994-01-07
K932048 SILICONE GEL SHEETING Silipos, Inc. MDA Class I 1994-01-07
K931737 HEDLEYL INTRAMEDULLARY PREPARATION BRUSH Synvasive Technology, Inc. HTZ Class I 1994-01-07
K930825 SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES Surgical Specialties, Inc. GAP Class II 1994-01-07
K931305 ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONS Cardiogenes GEX Class II 1994-01-07
K932038 SUTURE NONABSORBABLE- SILK, POLYESTER Surgical Specialties, Inc. GAT Class II 1994-01-07
K930772 ETHICON* MONOCRYL (POLIGLECAPRONE 25) SUTURE ETHICON, Inc. GAM Class II 1994-01-07
K932307 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM 3M Health Care, Ltd. KIJ Class I 1994-01-07
K930588 DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID Davis & Geck, Inc. GAM Class II 1994-01-07
K932037 SUTURE ABSORBABLE- GUT Surgical Specialties, Inc. GAR Class II 1994-01-07

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