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
147241–147264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1985
LITEGUARD 9
K851924 · LDD
Temtech , Ltd.
Cardiovascular · 96d
Cleared Aug 06, 1985
SARACAP RESPIRATORY MONITOR
K852062 · CCK
Alleghany Intl. Medical Technology
Anesthesiology · 89d
Cleared Aug 06, 1985
MEDTRONIC MODEL 5561
K852356 · DTD
Medtronic Vascular
Cardiovascular · 64d
Cleared Aug 06, 1985
CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA
K852435 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 57d
Cleared Aug 06, 1985
HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193
K853003 · JJE
Hi Chem, Inc.
Chemistry · 21d
Cleared Aug 06, 1985
DR. HESSEL'S VACUUM EXTRACTOR
K853037
Medic Group of Scandinavia, Inc.
General & Plastic Surgery · 19d
Cleared Aug 06, 1985
MCKNIFE
K853103 · GDX
Medical Dimensions
General & Plastic Surgery · 14d
Cleared Aug 06, 1985
ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR
K853114 · GAD
Australian Biomedical Corporation , Ltd.
General & Plastic Surgery · 13d
Cleared Aug 06, 1985
BEAVER MULTIPURPOSE SAPPHIRE KNIFE
K853129 · HNN
Rudolph Beaver, Inc.
Ophthalmic · 11d
Cleared Aug 06, 1985
RESPIR THER HUMID CONTAIN STERILE WATER FOR USP
K853146 · BTT
Automatic Liquid Packaging, Inc.
Anesthesiology · 8d
Cleared Aug 06, 1985
STERILE NASOPHARYNGEAL AIRWAY
K853162 · BTQ
Inmed Corp.
Anesthesiology · 7d
Cleared Aug 05, 1985
ELECTRICALLY HEATED STERILIZER STEAM STERILIZER
K844649 · FLE
Takizawa Medical Instruments...
General Hospital · 249d
Cleared Aug 05, 1985
OCCLUSION & OCCLUSION-IRRIGATION
K844918 · DQT
Clincal Instruments Corp.
Cardiovascular · 229d
Cleared Aug 05, 1985
BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI
K850952 · DYG
C.R. Bard, Inc.
Cardiovascular · 151d
Cleared Aug 05, 1985
AJDJUSTABLE SUCTION CONTROL VALVE
K851406 · DWD
American Omni Medical, Inc.
Cardiovascular · 118d
Cleared Aug 05, 1985
SILENT GUARD CAT. NO. SG-30
K851465 · DTL
American Omni Medical, Inc.
Cardiovascular · 116d
Cleared Aug 05, 1985
PHAKOSYSTEMS MODEL CES 4100
K851674 · HQC
Phakosystems, Inc.
Ophthalmic · 104d
Cleared Aug 05, 1985
EQUITEST
K851744 · LXV
Neurocom International, Inc.
Ear, Nose, Throat · 98d
Cleared Aug 05, 1985
ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO
K851854 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 101d
Cleared Aug 05, 1985
DEFI 2
K851931 · LDD
S & W Medico Teknik
Cardiovascular · 95d
Cleared Aug 05, 1985
TDX CORTISOL
K852927 · JFT
Abbott Laboratories
Chemistry · 27d
Cleared Aug 05, 1985
B-D DIGITAL FEVER THERMOMETER
K852954 · FLL
Bd Becton Dickinson Vacutainer...
General Hospital · 25d
Cleared Aug 02, 1985
SLEEP STAGER
K850541 · OLT
Oxford Medilog, Inc.
Neurology · 172d
Cleared Aug 02, 1985
STAT GAS MODULE
K851451 · KLK
Vulcan Laboratories, Inc.
Anesthesiology · 113d