FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
148393–148416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1985
AMERICAN BENTLEY OXYGENATOR MAX-2
K851035 · DTZ
American Bentley
Cardiovascular · 64d
Cleared May 16, 1985
NORELCO BLOOD PRESSURE METER
K851049 · DXN
Philips Park
Cardiovascular · 63d
Cleared May 16, 1985
UMI ANGIOGRAPHIC CATHETER
K851088 · DQO
Universal Medical Instrument Corp.
Cardiovascular · 59d
Cleared May 16, 1985
VASOSCREEN IMPEDANCE PLETHYSMOGRAPH
K851102 · DQB
Sonicaid, Inc.
Cardiovascular · 58d
Cleared May 16, 1985
TELEFLEX MEDICAL INTRODUCER CATHETER
K851141 · DYB
Teleflexmedical, Inc.
Cardiovascular · 56d
Cleared May 16, 1985
PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH
K851322 · DPS
Parexel Intl. Corp.
Cardiovascular · 44d
Cleared May 16, 1985
MARLIN CONTACT LENS CASE
K851497 · HPX
Marlin Industries
Ophthalmic · 31d
Cleared May 16, 1985
COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE
K851699 · DXY
Cook Pacemaker Corp.
Cardiovascular · 22d
Cleared May 16, 1985
STERILE GOWNS, MASKS & TOWELS
K851853
Biological & Environmental Control...
General & Plastic Surgery · 20d
Cleared May 16, 1985
PROGRAMALITH III MODEL 249 PULSE GENERATOR
K851861 · DXY
Pacesetter Systems
Cardiovascular · 20d
Cleared May 15, 1985
COPAL DIGITAL SPHYGMOMANOMETER UA-535
K843390 · DXN
Takeda Medical, Inc.
Cardiovascular · 259d
Cleared May 15, 1985
LABMASTER & CRSI 600
K843435 · FRF
Control Resource Systems, Inc.
General Hospital · 253d
Cleared May 15, 1985
DIGITAL SPHYGMOMANOMETER BP-2500
K843446 · DXN
Pollenex Associated Mills, Inc.
Cardiovascular · 252d
Cleared May 15, 1985
OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
K844849 · BSZ
Ohmeda Medical
Anesthesiology · 153d
Cleared May 15, 1985
VITALOG PMS-8
K845051 · DPZ
Vitalog Corp.
Anesthesiology · 147d
Cleared May 15, 1985
MARC MEDICAL PROBE COVER-200
K850424 · FLL
K&M Plastics
General Hospital · 100d
Cleared May 15, 1985
PROGRAMALITH III 240 PULSE GENERATOR
K850464 · DXY
Pacesetter Systems
Cardiovascular · 97d
Cleared May 15, 1985
LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES
K850508 · EGJ
Kal Life Systems
Physical Medicine · 96d
Cleared May 15, 1985
PEPSODENT DENTURE ADHESIVE CREAM
K850610 · EBD
Lever Brothers Company, Inc.
Dental · 89d
Cleared May 15, 1985
LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS
K850638 · MSJ
Behring Diagnostics, Inc.
Chemistry · 85d
Cleared May 15, 1985
LX120 TISSUE PROCESSOR
K851054 · IEO
Innovative Medical Systems, Inc.
Pathology · 62d
Cleared May 15, 1985
TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/
K851105 · EMG
The Huxley Instrument Corp.
Dental · 57d
Cleared May 15, 1985
R-1000 ECG RECEIVER
K851123 · DXH
Brentwood Instruments, Inc.
Cardiovascular · 57d
Cleared May 15, 1985
T-1000 ECG TRANSMITTER
K851124 · DXH
Brentwood Instruments, Inc.
Cardiovascular · 57d