Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER (K852115)Ars Enterprises, Inc.1985-11-01
ANTISERUM TO HUMAN APOLIPOPROTEIN A-I (K850691)Kent Laboratories, Inc.1985-11-01
DISPOSABLE STEAM BIOLOGICAL TEST PACK (K852192)Parke-Davis Co.1985-11-01
MENTOR BRIGHTNESS ACUITY TESTER (K853736)Mentor O & O, Inc.1985-11-01
PERSONAL AMPLIFIER SLIMLINE III (K853605)Electone, Inc.1985-11-01
TRAVENOL MULTIDAY INFUSOR 2C1080 (K842905)Travenol Laboratories, S.A.1985-11-01
MEDTRONICS MODELS 8320/8322/8329 (K852688)Medtronic Vascular1985-11-01
VESSA TREKKA (K853595)Vessa , Ltd.1985-11-01
BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS (K854143)Telectronics, Inc.1985-11-01
POLY-SLEEVE (K853631)CooperVision, Inc.1985-11-01
CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK (K852748)Cordis Corp.1985-11-01
LASER IRAS (K853556)Randwal Instrument Co., Inc.1985-11-01
ANTISERUM TO HUMAN PREALBUMIN (K850686)Kent Laboratories, Inc.1985-11-01
OHMEDA CPU AIR COMPRESSOR MODEL 3350 (K854306)Ohmeda Medical1985-11-01
STERICOVER (K853044)Sterimed, Inc.1985-11-01
PULMANEX (K854037)Life Design Systems, Inc.1985-11-01
MURRAY CHAIR LIFT (K854120)J.B. Murray Enterprises, Inc.1985-11-01
DUROMEDICS CARDIAC VALVE SIZER SET (K853313)Hemex Scientific, Inc.1985-11-01
RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000 (K853395)Raytheon Medical Systems1985-11-01
FAP-CATH (K852456)Research Medical, Inc.1985-11-01
PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (K853812)Biosan Laboratories, Inc.1985-11-01
MALLORY/HEAD TOTAL HIP SYSTEM (K853259)Biomet, Inc.1985-11-01
PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM (K852097)Medi-Tech, Inc.1985-11-01
SNAP-LOCK ADDITIVE CAP #SL 200 (K854032)Williams Medical Co.1985-11-01
SAFE.N.SURE (K852620)Ashai Co. , Ltd.1985-10-31
ILEX PROMPT CLINICAL CHEMISTRY ANALYER (K853068)Ilex Corp.1985-10-31
SDL-32 ELECTRONIC LINEAR SCANNER (K850834)Shimadzu Corp.1985-10-31
UNIVERSAL SERVICE MODULE (K851446)Diasonics, Inc.1985-10-31
UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-52 (K852362)Johnson & Johnson Professionals, Inc.1985-10-31
COLUMBIA 5% BLOOD AGAR (K854228)R. Kent Richards, Inc.1985-10-31
IRREGULAR CURVE TRACING REVISITION & DOPPLER (K853769)Hewlett-Packard Co.1985-10-31
AUSTENAL MODIFIED ACRYLIC DENTURE RESIN (K853160)Austenal Dental, Inc.1985-10-31
DB PRECISION IMPLANT SYSTEM (K853788)Driskell Bioengineering1985-10-31
ULTRACLONE 05-100 GUINEA PIG RBC (K854206)Earl-Clay Laboratories, Inc.1985-10-31
DENTAL CEMENT (K853431)Dentsply Intl.1985-10-31
DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM (K851860)Diasonics, Inc.1985-10-31
INTERPORE 200 POROUS HYDROXYAPATITE (K852975)Inrterpore Intl.1985-10-31
MICRO-MAT SYSTEM (K854121)Prevo Micro-Mat System1985-10-31
THROMBO SCREEN SICKLE CELL ASSAY SET (K854079)Pacific Hemostasis1985-10-31
PAXIAL (K853116)Biophysic Medical, Inc.1985-10-31
POLYCHROME IV STAIN (K854176)Devetec, Inc.1985-10-31
XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM (K853459)Xerox Medical Systems1985-10-30
MEDIPART BACTERIA FILTER MP-2615 (K853577)Medipart Jerry Alexander1985-10-30
PEAK FLOWMETERS FOR SPIROMETRY (K851265)Solcoor, Inc.1985-10-29
DMA OXYGEN MONITOR (K852823)Ferguson Medical1985-10-29
PLASTIC MOUTH BARRIER HSV-I (K853266)Westmark Enterprises, Inc.1985-10-29
GT HIP PROSTHESIS FEMORAL COMPONENT (K853169)Intermedics Orthopedics1985-10-29
MEDIPART DISPOS. NOSE CLIP MP-2001 (K853578)Medipart Jerry Alexander1985-10-29
DENTOCULT CULTURE-PADDLE (K851164)Orion Corp.1985-10-29
MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 (K853572)Medipart Jerry Alexander1985-10-29
BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. (K844446)Pulpdent Corp. of America1985-10-29
MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (K853574)Medipart Jerry Alexander1985-10-29
VISTECH VCTS GLARE TESTER (K853481)Vistech Consultants, Inc.1985-10-29
SUN TANNING BED (K853846)Tan America Mfg.1985-10-29
MEDIPART SODA LIME MP-3522 (K853571)Medipart Jerry Alexander1985-10-29
MEDIPART MOUTHPIECE MP-1010 (K853575)Medipart Jerry Alexander1985-10-29
DYNAMIC CARDIAC PHANTOM 74-347 (K853756)Victoreen, Inc.1985-10-29
SELECT FLOWMETER (K854067)Precision Medical, Inc.1985-10-29
FLS MED. PROD. RACINE TYPE ADAPTOR (K853828)Fls Medical Products, Inc.1985-10-29
MEDIPART FACE MASK HEADSTRAP MP-9100 (K853573)Medipart Jerry Alexander1985-10-29
FREEMAN HIP (K852839)Advanced Biosearch Assn.1985-10-29
WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL (K853640)Downs Surgical , Ltd.1985-10-29
FLUORESCENT T12 UVA TANNING LAMP (K854004)Light Sources, Inc.1985-10-29
MILLAR MIKRO-TIP DOPPLER CATHETER (K853138)Millar Instruments, Inc.1985-10-29
VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED (K853180)Keeler Instruments, Inc.1985-10-28
VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED (K853181)Keeler Instruments, Inc.1985-10-28
TDX AMPHETAMINE METHAMPHETAMINE (K853879)Abbott Laboratories1985-10-28
HITACHI 704 (K854025)Boehringer Mannheim Corp.1985-10-28
VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST (K853349)Varian Assoc., Inc.1985-10-28
WAVE GATE (K853412)Wolfline Corp.1985-10-28
ASTRA SYSTEMS CHOLESTEROL REAGENT (K853854)Beckman Instruments, Inc.1985-10-28
LASER ASO KIT (K854039)Behring Diagnostics, Inc.1985-10-28
THE CSE FILM CHANGER SYSTEM (K854251)Changer Service & Engineering, Inc.1985-10-28
OMNI PLANE SYSTEM (K854085)Xre Corp.1985-10-28
SIGMA 610 FOR PROTEIN IN URINE & CSF (K853681)Sigma Diagnostics, Inc.1985-10-28
MEVAPLAN AND SOMADOS (K852410)Siemens Medical Solutions USA, Inc.1985-10-28
UNIVERSAL STAND FOR FILM CHANGER (K853928)Canon USA, Inc.1985-10-28
TDX BARBITURATES (K854044)Abbott Laboratories1985-10-28
DMA CALIBRATORS (K854092)Data Medical Associates, Inc.1985-10-25
NML TSH IRMA (K854087)Organon Teknika Corp.1985-10-25
MICROVASIVE SILICONE SPRAY (K854063)Microvasive1985-10-25
ENDO-LASE CD40 FOR UROLOGY (K853904)Endo Lase, Inc.1985-10-25
LACTOPLATE (K852737)Mackeen Consultants, Ltd.1985-10-25
ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- (K853874)Endo Lase, Inc.1985-10-25
ACCURACY (K854119)Columbia Diagnostics, Inc.1985-10-25
FREEDOM LINE LUBRICATED MODELS LS-2-5, LT-6-10 (K852816)Apollo Dental Products, Inc.1985-10-24
ACUSON RADIOLOGY DOPPLER ACCESSORY (K852974)Acuson Computed Sonography1985-10-24
LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03 (K853519)Intermedics, Inc.1985-10-24
CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 (K853861)Canon USA, Inc.1985-10-24
TOP SUN MODELS 100,101,103 &139, 139-1, 139-3 (K853833)Top Sun America, Inc.1985-10-24
DIAGNOSTIC ECG DISPOSABLE ELECTRODE (K851522)Sentry Medical Products, Inc.1985-10-24
PHADIRECT STREP A TEST (K854150)Pharmacia, Inc.1985-10-23
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY (K851889)Clinical Data, Inc.1985-10-23
BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR (K854064)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-10-23
MANUAL VENTILATION ACCESSORY (K854036)Siemens Elema AB1985-10-23
COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI (K853590)Cook Pacemaker Corp.1985-10-23
750 SD ULTRASOUND SCANNER(MODIFICATION) (K851901)Ultrasonix, Inc.1985-10-23
OCS-2 COLPOSCOPE (K852980)Olympus Corp.1985-10-23
COMPANION 2800 VOLUME VENTILATOR (K851366)Puritan Bennett Corp.1985-10-23
TSK STERIJECT STERILE EPIDURAL NEEDLE (K854149)Pharmacia, Inc.1985-10-23
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Track 1985 automatically

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