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
159049–159072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1982
ULTRACHEM ENZYMATIC CHOL. OXIDASE
K822418 · CHH
Emd Chemicals, Inc.
Chemistry · 34d
Cleared Sep 14, 1982
SELF-CONTAINED MOBILE OPHTHAL. OPER. .
K822427 · FSE
Surgi-Quip Inc.U
General & Plastic Surgery · 33d
Cleared Sep 14, 1982
HCT CENTRIFUGE
K822445 · GKG
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Sep 14, 1982
SCISSORS, VARIOUS
K822448 · FZT
J. Sklar Mfg. Co., Inc.
General & Plastic Surgery · 29d
Cleared Sep 14, 1982
AURAFILL* DENTAL RESTORATIVE
K822450 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 29d
Cleared Sep 14, 1982
VISIO-OPAQUER
K822453 · EBF
Espe GmbH (Us)
Dental · 29d
Cleared Sep 14, 1982
YEAST AUTOLYXATE SUPPLEMENT
K822458 · JSK
Oxoid U.S.A., Inc.
Microbiology · 29d
Cleared Sep 14, 1982
VCAT ANTIBIOTIC SUPPLEMENT
K822459 · JSK
Oxoid U.S.A., Inc.
Microbiology · 29d
Cleared Sep 14, 1982
LCAT ANTIBIOTIC SUPPLEMENT
K822460 · JSK
Oxoid U.S.A., Inc.
Microbiology · 29d
Cleared Sep 14, 1982
N-S ANAEROBE SUPPLEMENT
K822461 · JSK
Oxoid U.S.A., Inc.
Microbiology · 29d
Cleared Sep 14, 1982
G-N ANAEROBE SUPPLEMENT
K822462 · JSK
Oxoid U.S.A., Inc.
Microbiology · 29d
Cleared Sep 14, 1982
ENZYMUNE SYSTEM I
K822465 · JJE
Icl Scientific
Chemistry · 29d
Cleared Sep 14, 1982
THROMBIN TIME TEST
K822466 · GJA
American Dade
Hematology · 29d
Cleared Sep 14, 1982
PSI TOTAL PROTEIN REAGENT
K822468 · CEK
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
PSI CALCIUM REAGENT
K822469 · CIC
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
PSI INORGANIC PHOSPHORUS
K822470 · CEO
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
PSI ALBUMIN REAGENT
K822471 · CIX
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
CHOLESTEROL STANDARD #65077
K822474 · JIS
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
TOTAL PROTEIN STANDARD, #65074
K822475 · JIT
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
PHOSPHOROUS STANDARD #65073
K822476 · JIS
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
ALBUMIN STANDARD, #65070
K822478 · JIT
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
BILIRUBIN CALIBRATOR #65071
K822479 · JIT
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
DEFLECTING CYTOLOGY BRUSH
K822490 · GEE
Van-Tec, Inc.
General & Plastic Surgery · 27d
Cleared Sep 14, 1982
DISPOSABLE TRANSDUCER & ACCESSORIES
K822507 · DRS
Gould, Inc.
Cardiovascular · 26d