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
174625–174648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1976
YASARGIL SUCTION TUBE - LARGE
K760746 · GCY
Codman & Shurtleff, Inc.
General & Plastic Surgery · 32d
Cleared Nov 01, 1976
YASARGIL SUCTION TUBE - MEDIUM
K760747 · GCY
Codman & Shurtleff, Inc.
General & Plastic Surgery · 32d
Cleared Nov 01, 1976
REAGENTS FOR BLOOD GAS INSTRUMENTATION
K760748 · CHL
Alko Scientific Co.
Chemistry · 66d
Cleared Nov 01, 1976
TERUMO DISPOSABLE SPINAL NEEDLE
K760775 · GAA
Terumo America, Inc.
General & Plastic Surgery · 28d
Cleared Nov 01, 1976
MISHLER 2 CHAMB FLUSHING VALVE,STAND
K760784 · JXG
Heyer Schulte Corp.
Neurology · 27d
Cleared Nov 01, 1976
MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH
K760785 · JXG
Heyer Schulte Corp.
Neurology · 27d
Cleared Nov 01, 1976
SPAC DIGOXIN KIT
K760800 · DON
Mallinckrodt Critical Care
Toxicology · 24d
Cleared Nov 01, 1976
TSH RIA KIT
K760801 · JLW
Diagnostic Products Corp.
Immunology · 20d
Cleared Nov 01, 1976
HISTOPLASMA MYCELIAL ANTIGEN
K760826 · GMJ
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
HISTOPLASMA YEAST ANTIGEN
K760827 · GMJ
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
BLASTOMYCES YEAST ANTIGEN
K760828 · JJJ
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
COCCIDIOIDES MYCELIAL ANTIGEN
K760829 · GMG
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ASPERGILLUS MYCELIAL ANTIGEN
K760830 · JWT
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL)
K760831 · GMK
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-HISTOPLASMA CONTROL SERUM (YEAST)
K760832 · GMK
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-BLASTOMYCES CONTROL SERUM (YEAST)
K760833 · KFH
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL)
K760834 · GMH
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-ASPERGILLUS CONT. SER. (MYCELIAL)
K760835 · KFG
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
NEGATIVE CONTROL SERUM
K760836
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
HEXCELITE SHEET SPLINTS
K760841 · ITG
Hexcel Medical
Physical Medicine · 19d
Cleared Nov 01, 1976
CONCHA-COLUMN
K760866 · BTT
Respiratory Care, Inc.
Anesthesiology · 14d
Cleared Nov 01, 1976
VEST RESTRAINT
K760868 · KNW
Orthopedic Equipment Co., Inc.
Gastroenterology & Urology · 14d
Cleared Nov 01, 1976
SPLIT CERVICAL COLLAR/HEAD HALTER
K760869 · HSS
Orthopedic Equipment Co., Inc.
Physical Medicine · 14d
Cleared Nov 01, 1976
HEEL/ELBOW FLOTATION CUSHION
K760870 · FMP
Medpro, Inc.
General Hospital · 14d