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
152689–152712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
K841533 · LAS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 25d
Cleared May 11, 1984
OMNIDIRECTIONAL POWERED WHEEL CHAIR
K841542 · ITI
Kinetic Concepts, Inc.
Physical Medicine · 25d
Cleared May 11, 1984
OPTIMATE DIGOXIN TEST
K841582 · KXT
Miles Laboratories, Inc.
Toxicology · 24d
Cleared May 11, 1984
KF STREPTOCOCCUS AGAR
K841658 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared May 11, 1984
SYNTHETIC BROTH A.O.A.C.
K841661 · JST
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared May 11, 1984
WALK & ROLL
K841700 · INM
Maddak, Inc.
Physical Medicine · 18d
Cleared May 11, 1984
DULBECCO'S PHOSPHATE BUFFERED SALINE
K841744 · KIT
Sigma Chemical Co.
Pathology · 14d
Cleared May 11, 1984
HEKTOEN ENTERIC AGAR
K841745 · JSI
The Montana Deaconess Medical Center
Microbiology · 14d
Cleared May 10, 1984
MEDPAR SURGICAL IMPLANTS
K832283 · FWP
Porex Medical
General & Plastic Surgery · 303d
Cleared May 10, 1984
IN-THE-EAR HEARING AID RX10 & 20
K840891 · ESD
Audio-Aid, Inc.
Ear, Nose, Throat · 73d
Cleared May 10, 1984
MULTIPLEX I, INTERFERENTIAL CURRENT
K841579 · IPF
Houwers Enterprises , Ltd.
Physical Medicine · 23d
Cleared May 10, 1984
MEDIUM FREQ. ELECTRICAL MUSCLE STIMULA
K841598
Chattanooga Group, Inc.
Physical Medicine · 22d
Cleared May 10, 1984
CRAWLER
K841695 · KNL
Maddak, Inc.
Physical Medicine · 17d
Cleared May 10, 1984
HEAT PACK
K841698 · IMA
Maddak, Inc.
Physical Medicine · 17d
Cleared May 09, 1984
CARDIO TRACE ELECTRODE
K832429 · DRX
Poly-Med Splint Co.
Cardiovascular · 292d
Cleared May 09, 1984
CENTURION CARDIAC DETECTOR
K832828 · DRJ
Clinical Data Instruments, Inc.
Cardiovascular · 264d
Cleared May 09, 1984
SONEL 3000A
K833223 · IYO
Cgr Medical Corp.
Radiology · 244d
Cleared May 09, 1984
FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN
K833593 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 210d
Cleared May 09, 1984
NARCOTRACE 40 - NT40
K833656 · DSF
Narco Bio-Systems
Cardiovascular · 202d
Cleared May 09, 1984
DIASONICS DLA-100
K833667 · IYO
Diasonics, Inc.
Radiology · 203d
Cleared May 09, 1984
BETAJECT BD U100
K833705 · FMI
Orange Medical Instruments, Inc.
General Hospital · 204d
Cleared May 09, 1984
GALLIE CRYONUCLEATOR
K833747 · HPS
Mono Research Laboratories
Ophthalmic · 196d
Cleared May 09, 1984
M305
K833819 · DXJ
Burkick Corp.
Cardiovascular · 189d
Cleared May 09, 1984
E 310 ELECTROCARDIOGRAPH
K833951 · DPS
Burdick Corp.
Cardiovascular · 176d