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
148849–148872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1985
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR
K850622 · LDF
Oscor Medical Corp.
Cardiovascular · 50d
Cleared Apr 10, 1985
PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD
K850652 · DTD
Pacesetter Systems
Cardiovascular · 50d
Cleared Apr 10, 1985
F-SERIES IMPLANT
K850706 · DZE
Omni Intl., Inc.
Dental · 47d
Cleared Apr 10, 1985
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER
K850760 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 44d
Cleared Apr 10, 1985
DENTAL MASSAGING PICKS
K850775 · JET
L.A.K. Ent., Inc.
Dental · 43d
Cleared Apr 10, 1985
MOBILE LEAD PLASTIC X-RAY BARRIERS
K850813 · IWX
Victoreen, Inc.
Radiology · 41d
Cleared Apr 10, 1985
MODULAR X-RAY BARRIERS
K850814 · EAK
Victoreen, Inc.
Radiology · 41d
Cleared Apr 10, 1985
LEAD PLASTIC VIEWING PANELS
K850816 · EAK
Victoreen, Inc.
Radiology · 41d
Cleared Apr 10, 1985
PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID
K850820 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 41d
Cleared Apr 10, 1985
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823 · IZO
Philips Medical Systems (Cleveland),...
Radiology · 41d
Cleared Apr 10, 1985
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 37d
Cleared Apr 10, 1985
GLAS IONOMER CEMENT
K850913 · EMA
Shofu Dental Corp.
Dental · 36d
Cleared Apr 10, 1985
TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER
K850948 · IXR
D&R X-Ray Products, Inc.
Radiology · 34d
Cleared Apr 10, 1985
BLOOD GAS SAMPLER KIT
K850958 · FMF
Churchill Corp.
General Hospital · 33d
Cleared Apr 10, 1985
HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR
K851011 · IZO
Hofmann X-Ray of America, Inc.
Radiology · 29d
Cleared Apr 10, 1985
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
K851079 · JJX
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Apr 10, 1985
PORTABLE DEFIBRILLATOR/MONITOR ED 425
K851092 · LDD
Honeywell, Inc.
Cardiovascular · 22d
Cleared Apr 10, 1985
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
K851104 · CEP
Amersham Corp.
Chemistry · 22d
Cleared Apr 10, 1985
IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH
K851294 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Apr 10, 1985
IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH
K851295 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Apr 10, 1985
IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET
K851297 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Apr 09, 1985
CARDIO-NEC MODEL 365
K844101 · DPS
Birtcher Corp.
Cardiovascular · 168d
Cleared Apr 09, 1985
IVAC DRUG ADMINISTRATION DEVICE
K844843 · FPA
Y
General Hospital · 117d
Cleared Apr 09, 1985
IAI PROGRAM-COMPUTER PROGRAM
K844997 · DXG
Intl. Acoustics, Inc.
Cardiovascular · 104d