Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
HSV LAPAROSCOPY SET (K941541)Henke Sass Wolf of America, Inc.1994-05-16
ONGARD 2 GALLON CHEMO SHARPS CONTAINER (K933674)Ongard Systems, Inc.1994-05-16
EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT (K941134)H & C Chemical, Inc.1994-05-16
KAVO INTRASEPT 905 (K934783)Kavo America1994-05-16
FLOWGUN ELECTROCAUTERY PROBE HANDLE (K935970)O.R. Concepts, Inc.1994-05-16
JARIT RECOMMENDED SINUS INSTRUMENTS (K941565)J. Jamner Surgical Instruments, Inc.1994-05-16
MICROVASIVE MAXFORCE (K934697)Boston Scientific Corp1994-05-16
DISPOSABLE PROPHYLAXIS ANGLE (K941189)Team Technologies, Inc.1994-05-16
SURESOFT SURGICAL GLOVES (K940218)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-05-16
URI-CATH CATHETER (K941672)Gesco Intl., Inc.1994-05-16
OPTODENT/OPTOGNATH (K936058)Spectrum Healthcare Group1994-05-16
ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS (K941364)Acufex Microsurgical, Inc.1994-05-16
WET SENSE (K935915)Edson Corp.1994-05-13
NERVE INTEGRITY MONITOR-2 (NIM-2 XL) (K934426)Xomed-Treace, Inc.1994-05-13
GRIDGIL (K941626)Gilardoni S.P.A.1994-05-13
PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION (K934722)Ohio Imaging, Inc.1994-05-13
CAPASEE (K933747)Toshiba America Medical Systems, In.C1994-05-13
PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS (K941734)Phonak, Inc.1994-05-13
HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 (K941764)Hi Chem, Inc.1994-05-13
PRO-CONNECT (K932269)Starkey Laboratories, Inc.1994-05-13
CIDBA CORNING ACS CORTISOL IMMUNOASSAY (K934317)Ciba Corning Diagnostics Corp.1994-05-13
TDA-4000/A4 (K941611)Toshiba America Medical Systems, In.C1994-05-13
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 (K934638)Koven Technology, Inc.1994-05-13
CENTRAL LINE DRESSING CHANGE TRAY (K941471)Clinical Resources, Inc.1994-05-12
LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S (K941955)Lorrex Health Products1994-05-12
WAX GUARD OPTION (K941039)Miracle-Ear, Inc.1994-05-12
AUDIOTONE MODEL A-54 (K941121)Miracle-Ear, Inc.1994-05-12
WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD (K935403)J-Lloyd Medical, Inc.1994-05-12
SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES (K940346)KARL STORZ Endoscopy-America, Inc.1994-05-12
IV START KIT (K941469)Clinical Resources, Inc.1994-05-12
DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY (K941468)Clinical Resources, Inc.1994-05-12
PEARL PACKING FORCEPS (K941528)Cook Urological, Inc.1994-05-12
STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE (K941302)Cush Industries, Inc.1994-05-12
SHARP II SEMI CONTOUR HEARING AID (K941293)Miracle-Ear, Inc.1994-05-12
THE EXPANDACELL SINUS PACK (K935724)Denver Splint Co.1994-05-12
SHARP II LOW PROFILE HEARING AID (K941294)Miracle-Ear, Inc.1994-05-12
HYDRO-M(TM) WOUND GEL (K940814)Kingston Technologies, Inc.1994-05-12
DISPOSABLE SUTURE PLACEMENT SYSTEM (K932553)Laurus Medical Corp.1994-05-12
CLESTRACLEAN(R) ROOM AIR PURIFIER (K932803)Clestra Cleanroom Technology, Inc.1994-05-12
LONZA FORMULATION R-82 (K932502)Lonza, Inc.1994-05-12
LAP SPONGE PRODUCT LINE (K941344)Cush Medical Products1994-05-12
ONTRAC STEERABLE GUIDEWIRE (K941229)Lake Region Mfg., Inc.1994-05-12
LONZA FORMULATION R-82 (K932277)Calgon Vestal Div.1994-05-12
MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST (K933811)Pitt Enterprises (Silicone) , Ltd.1994-05-12
FIXATION PIN (K931697)Orthologic Corp.1994-05-12
OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM (K934865)Trimedyne, Inc.1994-05-12
AUDIOTONE MODEL A-54SR (K941122)Miracle-Ear, Inc.1994-05-12
NYLON LINER GLOVES (K940274)Wells Lamont Corp.1994-05-12
GORE LAPAROSCOPIC SUTURE PASSER (K935986)W. L. Gore & Associates, Inc.1994-05-12
SAFE-PICC CATHETER (K930048)Menlo Care, Inc.1994-05-12
WOUND DRESSING KIT (K941467)Clinical Resources, Inc.1994-05-12
RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP (K936250)Medicon Instruments, Inc.1994-05-12
STERILE X-RAY DETECTABLE GAUZE SPONGES (K941522)Cush Medical Products1994-05-12
SHARP II FULL CONTOUR (K941292)Miracle-Ear, Inc.1994-05-12
LAPAROSCOPIC COVERED SURGICAL RETRACTOR (K933497)Advanced Surgical, Inc.1994-05-12
ENDOSURG DISPOSABLE SECONDARY TROCAR (K940036)Endosurg1994-05-12
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM (K934899)Telectronics Pacing Systems, Inc.1994-05-12
ISL QC 2000 LASER (K941694)Intelligent Surgical Lasers, Inc.1994-05-12
770-ATC (K941133)Electone, Inc.1994-05-12
IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED (K932924)Implex Corp.1994-05-12
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION (K934541)Scimed Life Systems, Inc.1994-05-12
PRESSURE IRRIGATING SYSTEM (K936223)Level 1 Technologies, Inc.1994-05-12
JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT (K925467)J.J. Skinner, Inc.1994-05-11
ACTION AT MANUAL WHEELCHAIR (K941989)Nvacare Corp.1994-05-11
ELIAS ENA SCREEN (MICROTITER PLATE) (K940622)Elias U.S.A., Inc.1994-05-11
SYN ENA SCREEN (PIN PLATE) (K940229)Elias U.S.A., Inc.1994-05-11
KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES (K935785)KARL STORZ Endoscopy-America, Inc.1994-05-11
JR. MICROCOAGULATION SYSTEM (K940401)International Technidyne Corp.1994-05-11
MICROSOMAL EIA TEST KIT (K941361)Immunoprobe, Inc.1994-05-11
THYROGLOBULIN EIA TEST KIT (K941358)Immunoprobe, Inc.1994-05-11
THORA-CATH (K941232)Gesco Intl., Inc.1994-05-11
KARL STORZ ELECTRONIC LAPAROFLATOR (K934114)KARL STORZ Endoscopy-America, Inc.1994-05-10
I-STAT 200 PORTABLE CLINICAL ANALYZER (K940918)I-Stat Corp.1994-05-10
LIGHTWRITER (K931855)Zygo Corp.1994-05-10
AFFINITY VENOUS RESERVIOR BAG (K935717)Avecor Cardiovascular, Inc.1994-05-10
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 (K935701)Starkey Laboratories, Inc.1994-05-10
INSUFFLATION TUBING & FILTER (K941094)H & C Chemical, Inc.1994-05-10
LIFETEK IUI CATHETER (K921518)Lifetek Medical, Inc.1994-05-10
CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 (K921727)Viggo-Spectramed1994-05-10
GLUCOFILM TEST STRIPS (K936212)Heraeus Kulzer, Inc.1994-05-10
MAGNUM (K932902)Sps, Inc.1994-05-10
UORCAP,MODEL NUMBER UDS-UCAP (K941105)Laborie Medical Tech, Inc.1994-05-10
DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS (K931474)Gbf Medical Group1994-05-10
TRACHEAL SUCTION CATHETER (K935600)Puritas Health Care, Inc.1994-05-10
HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION (K940462)KARL STORZ Endoscopy-America, Inc.1994-05-10
COMFEEL PLUS WOUND DRESSING (K941263)Richard Hamer Assoc., Inc.1994-05-10
KARL STORZ ELECTRONIC LAPAROFLATOR (K934043)KARL STORZ Endoscopy-America, Inc.1994-05-10
VALLEY MODEL E2750-T PENCIL GRIP LAPAROSCOPIC (K941968)Valleylab, Inc.1994-05-10
MODEL 222 CLINICAL AUDIOMETER (K934715)Virtual Corp.1994-05-10
SCOPEJOCKEY (K940780)Fibertech Instruments, Inc.1994-05-10
QUADRATURE SMALL EXTREMITY COIL (K935015)Magnetic Research, Inc.1994-05-10
URINARY ALBUMIN TEST PACK (K936202)Dupont Medical Products1994-05-09
SIME SURGICAL LATEX GLOVE (K940797)Sime Health, Ltd.1994-05-09
INSTRU KLENZ (K935063)Calgon Corp.1994-05-09
SUNGLASSES (K941529)Wesearch, Inc.1994-05-09
GLYCATED PROTEIN CALIBRATORS (K940008)Primus Corp.1994-05-09
POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) (K935864)Wembley Rubber Products (M) Sdn Bhd1994-05-09
AUTOMATIC NEEDLE DISCONECT (A.N.D.) (K925086)Post Medical, Inc.1994-05-09
ISOFLUX IXZ FLOW REGULATOR (K925732)Ferguson Medical1994-05-09
MICROARCH GOLD BRACKET (K932825)Gac Intl., Inc.1994-05-09
← Previous Next →

Track 1994 automatically

Every clearance here is in the API, with alerts when new ones post.