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
140041–140064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1987
TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER
K870729 · DTK
Medi-Tech, Inc.
Cardiovascular · 43d
Cleared Apr 09, 1987
EK10 ELECTROCARDIOGRAPH
K870880 · DPS
Burdick Corp.
Cardiovascular · 36d
Cleared Apr 09, 1987
INTRODUCER, PERCUTANEOUS
K870907 · DYB
Med Fusion Systems, Inc.
Cardiovascular · 35d
Cleared Apr 08, 1987
SZAC-16 SEIZURE ANALYSIS COMPUTER
K870450 · OMB
Grass-Telefactor Product Group
Neurology · 64d
Cleared Apr 08, 1987
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY
K870521 · JHI
Hybritech, Inc.
Chemistry · 61d
Cleared Apr 08, 1987
MLC NORMAL SERUM
K870580 · KIS
Rjo Biologicals, Inc.
Pathology · 56d
Cleared Apr 08, 1987
MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
K870963 · LIO
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 29d
Cleared Apr 08, 1987
CM 5000 MONITOR AIRWAY PRESSURE
K871083 · CAP
Canadian Monaghan , Ltd.
Anesthesiology · 21d
Cleared Apr 08, 1987
MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT
K871278 · LJP
California Integrated Diagnostics, Inc.
Microbiology · 8d
Cleared Apr 08, 1987
MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT
K871279 · JWZ
California Integrated Diagnostics, Inc.
Microbiology · 8d
Cleared Apr 08, 1987
FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339
K871284 · JIY
American Research Products Co.
Chemistry · 8d
Cleared Apr 08, 1987
GRAM IODINE
K871286 · HYI
Remel Co.
Pathology · 8d
Cleared Apr 07, 1987
MODIFICATION OF ACCU-CHEK II
K863481 · CGA
Boehringer Mannheim Corp.
Chemistry · 210d
Cleared Apr 07, 1987
FIBERBOND
K864376 · DYT
Dentec, Inc.
Dental · 153d
Cleared Apr 07, 1987
LIGHT-CURED PERIODONTAL DRESSING
K864720 · EMA
Dentsply Intl.
Dental · 125d
Cleared Apr 07, 1987
TRIGLYCERIDES DETERMINATION
K871122 · CDT
Biochemical Trade, Inc.
Chemistry · 18d
Cleared Apr 07, 1987
CUSTOM IN-THE-EAR HEARING AID
K871205 · ESD
Audiological Services, Inc.
Ear, Nose, Throat · 13d
Cleared Apr 07, 1987
HAND SURGERY TABLE EXTENSION
K871225 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 11d
Cleared Apr 06, 1987
CONTAC CASE
K863846 · LPN
S. M. C. Medi-Tech Corp.
Ophthalmic · 187d
Cleared Apr 06, 1987
MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.
K870149 · GEI
Radionics, Inc.
General & Plastic Surgery · 83d
Cleared Apr 06, 1987
CAPILLARY FLOW DIALYZERS
K870169 · FJI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 82d
Cleared Apr 06, 1987
MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM
K870249 · LYX
Bioclinical Laboratory Services, Inc.
Ophthalmic · 75d
Cleared Apr 06, 1987
MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM
K870250 · LYX
Bioclinical Laboratory Services, Inc.
Ophthalmic · 75d
Cleared Apr 06, 1987
CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM
K870251 · LYX
Bioclinical Laboratory Services, Inc.
Ophthalmic · 75d