Atlas FDA

1978

1,975 FDA 510(k) clearances · Clearance year

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RecordFirmDate
HBDH ENZYME KINETIC REAGENT SET (K781720)Medical Analysis Systems, Inc.1978-11-03
REAGENT SET, TOTAL PROTEIN (K781722)Medical Analysis Systems, Inc.1978-11-03
RECORDER, HOLTER ELECTROCARDIOGRAM (K781843)Hovik Corp.1978-11-03
AKRON MALE EXTERNAL CATHETER (K781433)Latex Ind., Inc.1978-11-03
GLUCOSE HEXOKINASE, AUTO K (K781723)Medical Analysis Systems, Inc.1978-11-03
MYO-STIM (K781239)Med General1978-11-03
TOMOGSCANNER 2 (K781753)Tomogscanner OK , Ltd.1978-11-03
CLINITEX VIS-X ASPIRATING ACCESSORY (K780852)Varian Assoc., Inc.1978-11-03
TINNITUS MASKER (K781798)Starkey Laboratories, Inc.1978-11-03
GAMMA RADIATION STERILIZATION PRECEDURE (K781668)Cutter Laboratories, Inc.1978-11-03
COPPER-TRAP (K781696)Olympic Medical Corp.1978-11-03
REAGENT SET, SGPT SERUM GLUTAMIC (K781726)Medical Analysis Systems, Inc.1978-11-03
AMPLAID MARK 4 AND MARK 5 (K781667)Amplaid USA, Inc.1978-11-03
CPK REAGENT SET, NAD REDUCTION (K781719)Medical Analysis Systems, Inc.1978-11-03
DISC, COLOPLAST PRE-OP STOMA (K781736)C.R. Bard, Inc.1978-11-03
REAGENT SET, U.V. ENZMATIC KINETIC, SGOT (K781725)Medical Analysis Systems, Inc.1978-11-03
REAGENT SET, CHOLESTEROL (K781721)Medical Analysis Systems, Inc.1978-11-03
IONOTPHORETIC APPLICATOR (K781700)Mcghan Medical Corp.1978-11-03
NAD REDUCTION METHOD, LACTATE PYRIVATE (K781724)Medical Analysis Systems, Inc.1978-11-03
LATEX, IN-HOUSE COMPOUNDED (K781847)Arbrook Mfg. Corp.1978-11-03
MAXI-CHAIR (K781801)Surgical Mechanical Research, Inc.1978-11-03
FRAME, UNIVERSAL DAY (K781793)B.G. Orthopedic Corp.1978-11-03
ALP REAGENT SET, ALKALINE PHOSPHATASE (K781718)Medical Analysis Systems, Inc.1978-11-03
ISO-CARE KIT (K781539)Nice-Pak Products, Inc.1978-11-03
LUBE-LOK (K781695)Olympic Medical Corp.1978-11-01
PREGELLED DISPOSABLE E.K.G. ELECTRODE (K781430)Vermont Medical, Inc.1978-10-31
EEG LEAD ASSEMBLY (K781494)Graphic Controls Corp.1978-10-31
MISTY-OX PREFILLED HUMIDIFIER, DISP. (K781600)Davco1978-10-31
VARIABLE STIFFNESS WIRE GUIDE (K781393)Cook, Inc.1978-10-30
CASTLE MODEL 3146 GAS AERATOR (K781484)Castle Co.1978-10-27
SRD-2 (K781646)Dynatech Laboratories, Inc.1978-10-27
PACING LEADS MODEL UL-811 AND UL-813 (K781776)Pacesetter Systems1978-10-27
RIA KIT, LH (K781685)Amersham Corp.1978-10-27
HEMO-W SYSTEM (K781628)Coulter Electronics, Inc.1978-10-27
AUTODILUTER 2 (K781645)Dynatech Laboratories, Inc.1978-10-27
STRAIN GAUGE PLETHYSMOGRAPH (K781352)Medimatic1978-10-27
MONITOR, GRAVITY IRRIGATION DRIP (K781717)Syntel, Inc.1978-10-27
PRESSURE, LOW/HIGH MODEL C1070 (K781697)Timeter Instrument Corp.1978-10-27
KENDRICK EXTRICATION DEVICE (K781761)Medi-Ked, Inc.1978-10-27
SERI-SEP SERUM/PLASMA ISLOLATOR (K781629)Wako Intl., Inc.1978-10-27
L-CYSTEINE HYDROCHLORIDE (K781690)Fisher Scientific Co., LLC1978-10-27
FILTER, ARTERIAL BLOOD W/TUBING BYPASS (K781707)Surgikos, Inc.1978-10-26
MEDIASTINAL DRAINAGE TUBE SET MDT-32TC2 (K781552)Sorensen Research1978-10-26
MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 (K781553)Sorensen Research1978-10-26
TRAUMA DRAINAGE SET 72T-28TTC (K781550)Sorensen Research1978-10-26
TRAUMA DRAINAGE SET 72T-32TTC (K781551)Sorensen Research1978-10-26
INTRA-ALERT (K781297)Pan-Tech Research, Inc.1978-10-25
DISPOSABLE LECTROSWITCH, MODEL E2503 (K781510)Valleylab, Inc.1978-10-24
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (K780958)Pittsburgh Micro-Media, Inc.1978-10-24
SODIUM CHLORIDE, 0.85% (K781734)Bioscientific1978-10-24
RIA, DIGOXIN (K781660)E. R. Squibb & Sons, Inc.1978-10-24
DIALYSIS SYS., PDS 400 & RO 400 (K781156)Physio-Control Corp.1978-10-24
STERILIZER, EAGLE 2000 (K781684)American Sterilizer Co.1978-10-24
LECTROSWITCH MODEL E2502B (K781511)Valleylab, Inc.1978-10-24
TRACHEOTOMY TUBES (K781729)Tracoe Medical GmbH1978-10-24
BILIRUBIN DETERMINTAITON IN SERUM (K781610)Fisher Scientific Co., LLC1978-10-24
MONOJECT SCALE MAGNIFIER (K781459)Sherwood Medical Industries1978-10-24
ORBIOGRAPH (K781543)Sonometrics Systems, Inc.1978-10-24
MOBIL XR (K781705)Siemens Corp.1978-10-24
MICROSURGURY VISIBILITY BACKGROUND (K781547)ETHICON, Inc.1978-10-24
MUELLER HINTON AGAR WITH THYMIDINE (K780959)Pittsburgh Micro-Media, Inc.1978-10-24
ENDOPROSTHESIS SYSTEM, VARIO-HEAD (K781735)Waldemar Link GmbH & Co. KG1978-10-24
BAYLOW VISUAL ACUITY TESTER (K781452)Codman & Shurtleff, Inc.1978-10-24
EAGLE PAC/VISIBLE SEAL (K781699)American Sterilizer Co.1978-10-24
SHILEY CRICOTHYROTOMY TUBE (K781639)Shiley, Inc.1978-10-24
EVALUSKOP (K781711)Siemens Corp.1978-10-24
BLADE, 20 ANGLE/MICRO BLADE HOLDER (K781716)Edward Weck, Inc.1978-10-24
MODEL 770 ARGON LASER (K781453)Spectra-Physics, Inc.1978-10-24
ALKALINE PHOSPHATASE IN SERUM (K781609)Fisher Scientific Co., LLC1978-10-24
CYTOMEGILISH TEST KIT (K781392)Microbiological Assoc.1978-10-24
SURG-O-PAK PREP PAD (K781534)Convertors1978-10-24
SCANNER, LINEAR (K781709)Philips Medical Systems (Cleveland), Inc.1978-10-24
CENTRAL CATHETER TRAY (K781333)Argon Medical Corp.1978-10-24
BUFFER, COLLAGEN REAGENT AND DILUENT (K781710)Diagnostica, Inc.1978-10-24
ASSAY SYSTEM, GAMMAFLO, AUTOMATED (K781659)E. R. Squibb & Sons, Inc.1978-10-24
CHOLESTEROL DET. IN SERUM (K781611)Fisher Scientific Co., LLC1978-10-24
RESPIRATORY EXERCISOR, VOLUME PULSE (K781669)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-10-23
PACEMAKER, MODEL 251-01 (K781568)Intermedics, Inc.1978-10-18
STREP-TEX (K781607)Burroughs Wellcome Co.1978-10-17
KIDNEY, ARTIFICIAL (K781153)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-10-17
SEPTAL BUTTON (K781529)Xomed, Inc.1978-10-17
UMBILICAL CORD CLAMP (K781548)Hollister, Inc.1978-10-17
PINT BOTTLE WELL (K781364)Baxa Corp., Sub. of Cook Group, Inc.1978-10-17
24-HOUR URINE COLLECTION COOLING WRAP (K781557)Sage Products, Inc.1978-10-17
OBJECTS PRECISION HANDLING TEST KIT (K781350)Metro. Hospital & Health Center1978-10-17
MIC-BIO-PLATE (K781506)Pasco Laboratories, Inc.1978-10-17
PROJECTOR, ACCU-CHART ACUITY (K781658)Bausch & Lomb, Inc.1978-10-17
RIA CONTROLS (K781593)Dade, Baxter Travenol Diagnostics, Inc.1978-10-17
PILLOWS- SINGLE PATIENT USE (K781354)Abco Dealers, Inc.1978-10-17
TECHNICON AUTOSLIDE STAINING/PROCESSING (K781598)Technicon Instruments Corp.1978-10-17
TOWELS, SHEETS, PILLOWCASES (K781227)Abco Dealers, Inc.1978-10-17
BACK TRAC (K781647)Tech Engineering, Inc.1978-10-17
IDENTI-LOOPS (K780720)Berkeley Bio-Medical, Inc.1978-10-17
THERMOMETER, DIGITAL ELEC. MODEL 4755 (K781661)British Aerospace, Inc.1978-10-17
NORMAL HEMATOLOGY CONTROL UNASSAYED (K781572)Ortho Diagnostics, Inc.1978-10-17
PHIPIOLOGICAL SYNCHRONIZER PART#205 (K781681)Brattle Instrument Corp.1978-10-17
ABNORMAL HEMATOLOGY CONTROL UNASSAYED (K781573)Ortho Diagnostics, Inc.1978-10-17
X-RAY STAND, PORTABLE (K781676)General X-Ray, Inc.1978-10-17
TERRY KERATOMETER (K781650)Clifford M. Terry, M.C.1978-10-17
RIA DIAG. TEST KIT FOR INDEXING THYROX. (K781560)Nuclear Diagnostics, Inc.1978-10-17
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