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
148969–148992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1985
LEECO CONCEP-7-BHCG EIA
K850531 · JHI
Leeco Diagnostics, Inc.
Chemistry · 50d
Cleared Apr 02, 1985
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K850570 · JHI
American Dade
Chemistry · 48d
Cleared Apr 02, 1985
MODEL SERUM HCG ASSAY
K850730 · JHI
Monoclonal Antibodies, Inc.
Chemistry · 39d
Cleared Apr 02, 1985
TRI-MED MODEL 112 MOISTURE TRAP
K850745 · CCK
Tri-Med, Inc.
Anesthesiology · 36d
Cleared Apr 02, 1985
TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI
K850746 · CCK
Tri-Med, Inc.
Anesthesiology · 36d
Cleared Apr 02, 1985
TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR
K850747 · CCK
Tri-Med, Inc.
Anesthesiology · 36d
Cleared Apr 02, 1985
MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT
K850779 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 35d
Cleared Apr 02, 1985
DROPSTIRS - PLASTIC DISPOSABLE PIPET
K850800 · JQW
Berwick Medical Products, Inc.
Chemistry · 34d
Cleared Apr 02, 1985
EMIT D.A.U. PROPOXYPHENE ASSAY
K850920 · JXN
Syva Co.
Toxicology · 28d
Cleared Apr 01, 1985
PHYSIOLOGICAL MONITOR 2100
K844353 · DXN
Datascope Corp.
Cardiovascular · 143d
Cleared Apr 01, 1985
APPLIED GAUZE SPONGE 4X4X16 PLY
K844673 · EFQ
Applied Medical
General & Plastic Surgery · 122d
Cleared Apr 01, 1985
APPLIED GAUZE SPONGE 2X2X8 PLY
K844674 · EFQ
Applied Medical
General & Plastic Surgery · 122d
Cleared Apr 01, 1985
APPLIED GAUZE SPONGE 3X3X12
K844675 · EFQ
Applied Medical
General & Plastic Surgery · 122d
Cleared Apr 01, 1985
APPLIED GAUZE SPONGE 4X4X8
K844676 · EFQ
Applied Medical
General & Plastic Surgery · 122d
Cleared Apr 01, 1985
APPLIED GAUZE SPONGE 2X2X12
K844677 · EFQ
Applied Medical
General & Plastic Surgery · 122d
Cleared Apr 01, 1985
GAUZE ASORBABLE
K844702 · EFQ
Medicon, Inc.
General & Plastic Surgery · 119d
Cleared Apr 01, 1985
GAUZE SPONGE 4X4X12 PLY
K844726 · EFQ
Applied Medical
General & Plastic Surgery · 118d
Cleared Apr 01, 1985
DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX
K844839 · DXN
Critikon Company, LLC
Cardiovascular · 110d
Cleared Apr 01, 1985
SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -
K844910 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 104d
Cleared Apr 01, 1985
CSR WRAP - CENTRAL SUPPLY ROOM WRAP FOR STERIL-
K844920 · FRG
Papeteries Depont-Audemer
General Hospital · 103d
Cleared Apr 01, 1985
MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT
K844976 · FSA
Medi-Man Rehabilitation Products, Inc.
General Hospital · 96d
Cleared Apr 01, 1985
FLO-PHORESIS - DESENSITIZER
K844989 · EGS
Eastco, Inc.
Dental · 96d
Cleared Apr 01, 1985
SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE
K844995 · BXB
Cropper Medical, Inc.
Physical Medicine · 96d
Cleared Apr 01, 1985
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
K850239 · GIF
Toa Medical Electronics USA, Inc.
Hematology · 69d