Atlas FDA

1991

4,235 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
ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 (K912363)Hitachi Medical Corp. of America1991-08-27
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS (K913429)Syva Co.1991-08-26
HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM)) (K912290)Boston Medical Products, Inc.1991-08-26
GARDNER PINS (ADULT & CHILD) (K911772)Codman & Shurtleff, Inc.1991-08-26
KODAK EKTACHEM DT SLIDES (ALB) (K913195)Eastman Kodak Company1991-08-26
KODAK EKTACHEM DT SLIDES (LAC) (K913197)Eastman Kodak Company1991-08-26
LITEBOX (K913252)Siemens Gammasonics, Inc.1991-08-26
INNERVISION IRRIGATION PUMP (K910982)M.D. Engineering, Inc.1991-08-26
ATRIUM 2000 CHEST DRAIN (K912704)Atrium Medical Corp.1991-08-26
BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY (K913091)American Laboratory Products Co., Ltd.1991-08-26
PHILIPS S1594 OTB HEARING AID (K913389)Philips Hearing Instruments Co.1991-08-26
BREATHING FILTERS (K911427)Intersurgical, Inc.1991-08-26
MINXRAY P300 X-RAY SYSTEM (K911841)Minxray, Inc.1991-08-26
MODIFICATION MANUAL RESUSCITATOR (PMR 2) (K913370)Puritan Bennett Corp.1991-08-26
DEVON SPONGE COUNTER BAGS (K912824)Devon Industries, Inc.1991-08-26
NEW-VENT (K911809)Concord/Portex1991-08-26
LIFECARE 4100 PCA INFUSER PLUS II (K912928)Abbott Laboratories1991-08-26
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV (K910921)United States Surgical, A Division of Tyco Healthc1991-08-26
URINE COLLECTION KIT/DEVICE (K913330)Medical Implements, Inc.1991-08-26
KODAK EKTACHEM DT SLIDES (CHE) (K913198)Eastman Kodak Company1991-08-26
MULTICAM I 8X10 (K912341)Camtronics, Ltd.1991-08-26
DIGISTORE 2100 (K912896)Enhanced Imaging Technologies, Inc.1991-08-26
MODEL #M9 ULTRACLAVE STEAM STERILIZER (K911322)Midmark Corp.1991-08-26
AUTOCOMP (K911340)Victoreen, Inc.1991-08-26
M32 IN-THE-EAR HEARING AID (K913390)Philips Hearing Instruments Co.1991-08-26
INTELIJET TM FLUID MANAGEMENT SYSTEM (K912453)Smith & Nephew Dyonics, Inc.1991-08-26
J105 JAMES SURGICAL SYSTEM I/A PACK (K911932)O.R. Specialties, Inc.1991-08-26
P.F.C. UNICONDYLAR KNEE SYSTEM (K910968)Johnson & Johnson Orthopaedics, Inc.1991-08-26
OPEN HEART TRAY (K912053)Medical Device Inspection Co., Inc.1991-08-26
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS (K913190)Syva Co.1991-08-26
ABUSCREEN(R) ONLINE(TM) CONTROLS (K913336)Roche Diagnostic Systems, Inc.1991-08-26
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE (K912755)Roche Diagnostic Systems, Inc.1991-08-26
ABUSCREEN(R) ONLINE(TM) CALIBRATORS (K913335)Roche Diagnostic Systems, Inc.1991-08-26
KAVOKLAVE STEAM AUTOCLAVE (K910789)Kavo America1991-08-26
OXICOMPLUS (K911207)Waters Instruments, Inc.1991-08-26
DYNEX IIIB, MODEL 89002026 (K913594)Medtronic Vascular1991-08-23
CONTOUR-PORT (K912540)Ideal Medical, Inc.1991-08-23
V-ACCI-GUARD(TM) REUSABLE HOLDER (K913329)Medical Safety Products, Inc.1991-08-23
HUENE FIXATION SCREW (K910193)Acu-Med, Inc.1991-08-23
IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER (K912918)Iriderm Div.1991-08-23
MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS (K913043)Tecnol New Jersey Wound Care, Inc.1991-08-23
CURAY SUPPORT (K912788)Scientific Pharmaceuticals, Inc.1991-08-23
BBL(R) DMACA INDOLE REAGENT DROPPERS (K912480)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-08-23
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED (K911777)Helena Laboratories1991-08-22
VENETO COLLECTION (K912034)Atlantic Optical Co., Inc.1991-08-22
GAP-IGG (K900343)Biomerica, Inc.1991-08-22
BACTI-SWAB(TM) NPG (K912832)Remel Co.1991-08-22
JUSTONE(TM) (K912846)Sensititre Microbiology A Div. of Radiometer1991-08-22
BIOCHEM TEMPERATURE/ FIO2 MODULE (K910381)Biochem International, Inc.1991-08-22
BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP (K911351)Biochem International, Inc.1991-08-22
MONARCH SYSTEM (K911051)Baxter Healthcare Corp1991-08-22
CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM (K912240)Mallinckrodt Anesthesia Products1991-08-22
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH (K912317)Schneider Intl., Ltd.1991-08-22
EMS/400 (K913272)Altoona Medical Supply1991-08-22
DAVIS & GECK CHROMIC & PLAIN GUT LIGATURE CARRIER (K912319)Davis & Geck, Inc.1991-08-22
BIOPHYSIOMETER POSITIONING CHAIR (K912320)Bi-Dynamics, Inc.1991-08-22
DANBY-DCR VOLUMETRIC INFUSION PUMP (K912914)Danby Medical , Ltd.1991-08-22
ARACHIDONIC ACID (K912774)Helena Laboratories1991-08-22
MODEL 4220 (K913134)Pace Medical1991-08-22
TITANIUM CATHETER EXTENDER (K910785)Accurate Surgical Instruments Co.1991-08-22
SPECTROLYSE PLASMINOGEN SK KIT (K912025)Biopool AB1991-08-22
GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) (K912613)Sensititre Microbiology A Div. of Radiometer1991-08-22
INTRAORAL DENTAL WAX (K910676)Pemaco, Inc.1991-08-21
MATRX, PYRAMID TRIANGLE BANDAGE (K912661)Matrix Medica, Inc.1991-08-21
STAR*SHADES(TM) SUNGLASSES (K912608)Nalpac , Ltd.1991-08-21
LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS (K910828)Ocular Instruments, Inc.1991-08-21
OSTEOMED SBF SYSTEM (SBF) (K911936)Osteomed Corp.1991-08-21
ALGINATE FIBER (K905040)Shepherd Medical Corp.1991-08-21
UHMWP ACETABULAR COMPONENT (K912426)Howmedica Corp.1991-08-21
POLYESTER RESIN HAND MOLDED TRAY (K912820)E&D Dental Products, Inc.1991-08-21
MODEL SCR-1000 (K913400)Accucore, Inc.1991-08-21
MICROSURGE LASER FIBER HOLDER (K912332)Microsurge, Inc.1991-08-21
PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM) (K912853)Precision Laser Products, Inc.1991-08-20
DEGUBOND LITE (K912493)Degussa AG1991-08-20
CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM (K912708)Kuraray Co.1991-08-20
AVI MODEL 270CI INFUSION PUMP (K912875)3M Avi, Inc.1991-08-20
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT (K911789)Medtronic Vascular1991-08-20
SCREW, BONE, MAXILLOFACIAL (K911165)Tekno-Medical1991-08-20
SILON(TM) TRANSPARENT WOUND DRESSING (K912032)Bio Med Sciences, Inc.1991-08-20
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM (K904625)Synectics-Dantec1991-08-20
L-LINEX-RAY FLUORESCENCE (K911749)Montifore Medical Center1991-08-20
SPECTRAL EEG MONITOR MODEL B500 (K913051)Biometrak Corp.1991-08-20
HEART CATH TRAY (K912052)Medical Device Inspection Co., Inc.1991-08-20
SKIN SAVER(TM) TUBING HOLDER, MODEL 467 (K912197)Alpine Specialties, Inc.1991-08-20
CLEARFIL LINER BOND SYSTEM (K912707)Kuraray Co.1991-08-20
ENDO-CORE (K912720)Metalor Dental USA Corp.1991-08-20
AUROFILM MP (K912721)Metalor Dental USA Corp.1991-08-20
NOZOVENT, NASAL DILATOR (K904290)Wpm Intl AB Intl Trade & Managemet Consulting1991-08-20
DRAINAGE CATHETERS W/A DISSOLVABLE TIP (K900205)Boston Scientific Corp1991-08-20
MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP (K912266)Orothmet, Inc.1991-08-20
SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION (K912078)3M Health Care, Sarns1991-08-20
MINITROP AEROSOL UNIT (K912566)Heyer America, Inc.1991-08-20
I.V. SKY-HOOK (K912010)Dina - Industria, Comercio E Exportacao , Ltd.1991-08-19
BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF (K912284)Douglas James Donaldson Compliance Services1991-08-19
22MM ID/OD ADAPTER (K911263)Monaghan Medical Corp.1991-08-19
AGC REVISION KNEE PROTHESIS (K912245)Biomet, Inc.1991-08-19
UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 (K905107)Universal Technology Systems, Inc.1991-08-19
SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K910342)Medison Co., Ltd.1991-08-19
EAGLE NUCLEAR IMAGING SYSTEM (K911290)Trionix Research Laboratory, Inc.1991-08-19
MR-5200 FULL DISCLOSURE SYSTEM (K911257)Mennen Medical, Inc.1991-08-19
← Previous Next →

Track 1991 automatically

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