Atlas FDA

1990

4,721 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ABBOTT SPECTRUM URIC ACID REAGENT KIT (K896954)Abbott Laboratories1990-02-23
TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) (K896829)Technicon Instruments Corp.1990-02-23
CARBON DIOXIDE REAGENT (K896812)Pointe Scientific, Inc.,1990-02-23
BICORE VARIFLEX(R) FLOW TRANSDUCER (K896718)Bicore Monitoring Systems1990-02-22
VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B (K900115)Ventlab Corp.1990-02-22
TRACHEOSTOMY TRAY (K896798)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-22
SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART (K895740)Lumex, Inc.1990-02-22
S-ROM(TM)/NOILES(TM) MARK 5 KNEE (K896397)Joint Medical Products Corp.1990-02-22
TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING (K895971)Telectronics Pacing Systems, Inc.1990-02-22
ACCU-BEAM WAVEGUIDE (K895656)Tti Medical1990-02-22
GRANITEC Z2, ZINC PHOSPHATE CEMENT (K896649)Confi-Dental Products Co.1990-02-22
CRAGG CONVERTIBLE WIRE (K897152)Boston Scientific Corp1990-02-22
KELLER PULSE OXIMETER - KMS 850 (K895987)Keller Medical Specialties Products, Inc.1990-02-22
LORENZ STENT (K896667)Walter Lorenz Surgical, Inc.1990-02-22
TYPE EXPIRED CO2 9270, CAPNOGRAPH (K895001)S & W Medico Teknik1990-02-22
MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID (K900238)Miracle-Ear, Inc.1990-02-22
BIOPOTENTIAL SURFACE ELECTRODE (K900059)Integral Design, Inc.1990-02-22
OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM (K897157)Trimedyne, Inc.1990-02-22
SPATULA FOR PAP SMEAR COLLECTION (K893229)Medical Device Inspection Co., Inc.1990-02-22
MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID (K900237)Miracle-Ear, Inc.1990-02-22
ACU-BAND ACCUPRESSURE WRIST BAND (K900588)Euro-Am Pharma, Inc.1990-02-22
BOOSTER MOTORIZED THREE WHEELED VEHICLE (K900738)Burke Mobility Products1990-02-22
DEN-MAT LAMI-QUICK (K895269)Den-Mat Corp.1990-02-22
STERILE SURGEON'S GLOVES (C T R GLOVES) (K895230)Tan D. W. Trading Co., Inc.1990-02-22
MODEL 219 TELEMETRY SYSTEM (K895895)Mennen Medical, Inc.1990-02-22
PRIMER-P ADHESIVE AGENT (K896719)Parkell1990-02-22
STEAM STERILIZER (AUTOCLAVE), DENTAL (K895638)Porter Instrument Co., Inc.1990-02-22
LOPER CELIAC PLEXUS BLOCK CATHETER KIT (K895955)Opticon Medical, Inc.1990-02-22
HALUX EXLITE MINOR SURGERY LIGHT (K896961)Jedmed Instrument Co.1990-02-22
3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12 (K900108)3M Company1990-02-21
WOODLYN SLIT LAMP MODEL HR-1 (K900476)Woodlyn, Inc.1990-02-21
WOODLYN CLASSIC SLIT LAMP MODEL SMM (K900477)Woodlyn, Inc.1990-02-21
HYDRASORB(TM) (K897156)Avitar, Inc.1990-02-21
WOODLYN FULL APERTURE TRIAL LENS SET (K900478)Woodlyn, Inc.1990-02-21
3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8 (K900244)3M Company1990-02-21
TOI-LIFT (K896814)Mill-Tech Ent., Inc.1990-02-20
ULTRA (THERAPEUTIC ULTRASOUND DEVICE) (K895690)Excel Tech. , Ltd.1990-02-20
SKYTRON MODEL 1100 AND MODEL 142 (K900290)Skytron, Div. the Kmw Group, Inc.1990-02-20
EXCEL STIM (K896836)Excel Tech. , Ltd.1990-02-20
4 SURE URINARY DRAIN BAG (K896727)The Boston & Pacific Co., Inc.1990-02-20
SORBEX(TM) SOFT SPONGE (K895654)Fountain Pharmaceuticals, Inc.1990-02-20
EMS 8100 (K895301)Henley Intl.1990-02-20
DANNIFLEX CPM 880(TM) (K900581)Buckman Co., Inc.1990-02-20
TRI-SCOOT FRONT WHEEL DRIVE POWERED SCOOTER (K900600)Invacare Corp.1990-02-20
EXCEL STIM II (K896908)Excel U.S.A.1990-02-20
4 SURE URINARY LEG BAG (K896728)The Boston & Pacific Co., Inc.1990-02-20
MULTISTIM PLUS (K895983)Excel Tech. , Ltd.1990-02-20
SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY (K896762)Sharplan Lasers, Inc.1990-02-16
EXEL INDWELLING CATHETER (K895772)Exel Intl.1990-02-16
EXEL HUBER NEEDLE (K895769)Exel Intl.1990-02-16
RHINOTHERM ULTRA 2 (K894734)Twinmed Products, Inc.1990-02-16
COBAS READY PROFILE 1 REAGENT STRIP (K896229)Roche Diagnostic Systems, Inc.1990-02-16
QUIDEL GROUP B STREP TEST (K896265)Quidel Corp.1990-02-16
WILLIAMS PENILE ANESTHETIC RETAINER (K896160)Cook Urological, Inc.1990-02-16
COBAS READY STAT PROFILE REAGENT STRIP (K896234)Roche Diagnostic Systems, Inc.1990-02-16
CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN (K900448)E.I. Dupont DE Nemours & Co., Inc.1990-02-16
COBAS READY ALT REAGENT (K896237)Roche Diagnostic Systems, Inc.1990-02-16
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT (K896587)Medix Biotech, Inc.1990-02-16
A-SCAN ROLL-AROUND STAND (K900161)Jedmed Instrument Co.1990-02-16
CHOLESTEROL TEST KIT (K895951)Elite Technology, Inc.1990-02-16
COBAS READY TRIGLYCERIDE REAGENT (K896231)Roche Diagnostic Systems, Inc.1990-02-16
SUCTION CATHETER KIT (K896797)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-16
IMAGES-ON-CALL TELERADIOLOGY SYSTEM (K896095)Devices & Services Co.1990-02-16
AUTOPEN (K895890)Ulster Scientific, Inc.1990-02-16
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT (K896845)Reagents Applications, Inc.1990-02-16
CANTATA EMG/EVOKED RESPONSE SYSTEM (K896567)Dantec Medical, Inc.1990-02-16
4 SURE UROLOGICAL CATHETER (K896725)The Boston & Pacific Co., Inc.1990-02-16
MODEL 2800 ND:YAG OPHTHALMIC LASER (K897099)Alcon Surgical, Inc.1990-02-16
SAFECON CONDOMS - PINK COLOR (K896623)Quality Synthetics Intl, Inc.1990-02-16
KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT (K896440)Kenlor Industries, Inc.1990-02-16
CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE (K896935)Baxter Healthcare Corp1990-02-16
COBAS READY URIC ACID REAGENT (K896227)Roche Diagnostic Systems, Inc.1990-02-16
CENTRIPREP 100 (K900280)Amicon, Inc.1990-02-16
MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) (K900063)Bio-Feedback Systems, Inc.1990-02-16
COBAS READY TOTAL PROTEIN REAGENT (K896230)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY AST REAGENT (K896238)Roche Diagnostic Systems, Inc.1990-02-16
EXEL SAFELET CATHETER (K895768)Exel Intl.1990-02-16
DISPOSABLE URODYNAMIC CATHETER SET (K896784)Life-Tech Intl., Inc.1990-02-16
COBAS READY CHOLESTEROL REAGENT (K896239)Roche Diagnostic Systems, Inc.1990-02-16
EXEL SPINAL NEEDLES (K895771)Exel Intl.1990-02-16
FLAT VASCULAR PROBE (K896613)Imex Medical Systems, Inc.1990-02-16
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 (K896170)Helena Laboratories1990-02-16
COBAS READY CARDIO PROFILE REAGENT STRIP (K896228)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY LDH REAGENT (K896241)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY LIVER PROFILE REAGENT STRIP (K896233)Roche Diagnostic Systems, Inc.1990-02-16
IVEX MODEL NO. BP 3000 BREASTPUMP (K893545)Ivex Medical, Inc.1990-02-16
MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM (K900070)Dyonics, Inc.1990-02-16
MODIFIED PARAMAX URIC ACID REAGENT (K896521)Baxter Healthcare Corp1990-02-16
CRONEX COMPACT MAMMOGRAPHY CASSETTE (K895335)E.I. Dupont DE Nemours & Co., Inc.1990-02-16
PORT INFUSION SET (PIS) INFUSION SET (IS) (K897065)Prn Services, Inc.1990-02-16
SURGICAL GLOVES (K895018)Lon Tai Chemical Industrial Co., Ltd.1990-02-16
MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS (K896949)Innovative Products Mfg.1990-02-16
DGH A-SAN PROBE HOLDER (K900162)Jedmed Instrument Co.1990-02-16
P460, DG32 ELECTROENCEPHALOGRAPH (K896666)Teca, Inc.1990-02-16
COBAS READY CK REAGENT (K896240)Roche Diagnostic Systems, Inc.1990-02-16
BIO FLOTE(R) (K900131)Bio Clinic Co.1990-02-16
QUICKIE P300 WHEELCHAIR (K900330)Quickie Designs, Inc.1990-02-15
UNI-POLAR HEAD (K896580)Richards Medical Co., Inc.1990-02-15
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE (K897192)Baxter Healthcare Corp1990-02-15
STORZ FIBEROPTIC ENDO-ILLUMINATORS (K896549)Storz Instrument Co.1990-02-15
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Every clearance here is in the API, with alerts when new ones post.