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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
101881–101904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1995
SAS SALMONELLA O GROUP D ANTIGEN
K952142 · GNC
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS BRUCELLA ABORTUS ANTIGEN
K952147 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
FORGED CEMENTED STEM
K952191 · JDI
Encore Orthopedics, Inc.
Orthopedic · 69d
Cleared Jul 17, 1995
ACTIVE INTACT PTH ELISA
K952199 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 68d
Cleared Jul 17, 1995
STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB...
K952250 · JHS
Dade Intl., Inc.
Chemistry · 63d
Cleared Jul 17, 1995
ACTIVE FREE TESTOSTERONE RIA
K952281 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 62d
Cleared Jul 17, 1995
AMERLITE HCG-60 ASSAY
K952283 · DHA
Johnson & Johnson Clinical...
Chemistry · 62d
Cleared Jul 17, 1995
FOUNDATION TEXTURED STEM
K952297 · LWJ
Encore Orthopedics, Inc.
Orthopedic · 62d
Cleared Jul 17, 1995
SURGISCAN SCANNER
K952299 · GEX
Norcross Scientific
General & Plastic Surgery · 62d
Cleared Jul 17, 1995
JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE...
K952350 · LWE
Promedical , Ltd.
General Hospital · 59d
Cleared Jul 17, 1995
GS & GS20 SURGICAL TOOL SYSTEM
K952463 · GET
Midas Rex Pneumatic Tools, Inc.
General & Plastic Surgery · 52d
Cleared Jul 17, 1995
ENDOCARE MONOPOLAR ELECTRODES
K952587 · GEI
Cytocare, Inc.
General & Plastic Surgery · 42d
Cleared Jul 17, 1995
N/T PROTEIN CONTROL SY/L, M AND H
K952593 · DAD
Behring Diagnostics, Inc.
Immunology · 41d
Cleared Jul 17, 1995
N PROTEIN STANDARD SY
K952594 · CZW
Behring Diagnostics, Inc.
Immunology · 41d
Cleared Jul 17, 1995
MEGABEAM ENDO-ENT PROBE
K952772 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 31d
Cleared Jul 17, 1995
SABRE MULTI-USE TROCAR SYSTEM
K952977 · GCJ
Endoscopic Concepts, Inc.
General & Plastic Surgery · 20d
Cleared Jul 14, 1995
SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE
K926253 · JKA
Sudormed, Inc.
Toxicology · 942d
Cleared Jul 14, 1995
CAP-STIK
K934435 · FMI
Mcshane Medical, Inc.
General Hospital · 690d
Cleared Jul 14, 1995
STC COCAINE METABOLITE EIA
K934775 · DIO
Solarcare, Inc.
Toxicology · 647d
Cleared Jul 14, 1995
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN...
K935564 · JKA
Sudormed, Inc.
Toxicology · 603d
Cleared Jul 14, 1995
OPIATES MICRO-PLATE ASSAY
K935565 · DJG
Solarcare Technologies Corp,Inc.
Toxicology · 603d
Cleared Jul 14, 1995
AMPHETAMINES MICRO-PLATE EIA
K935573 · DKZ
Solarcare Technologies Corp,Inc.
Toxicology · 603d
Cleared Jul 14, 1995
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN...
K935588 · JKA
Sudormed, Inc.
Toxicology · 604d
Cleared Jul 14, 1995
ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
K942543 · DXN
Sankei Co., Ltd.
Cardiovascular · 445d