FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126937–126960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1990
CUFFED LINDER NASOTRACHEAL AIRWAY
K900457 · BTR
Polamedco, Inc.
Anesthesiology · 76d
Cleared Apr 16, 1990
AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)
K900571 · CIG
American Research Products Co.
Chemistry · 68d
Cleared Apr 16, 1990
HYPO-ALLERGENIC SURGICAL GLOVES
K900669 · KGO
Modern Rubber Industrial Co., Ltd.
General Hospital · 66d
Cleared Apr 16, 1990
RDW AND MPV INDICES ON HEMAT 12
K900684 · GKZ
Texas Intl. Laboratories, Inc.
Hematology · 63d
Cleared Apr 16, 1990
CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
K900685 · KQG
Texas Intl. Laboratories, Inc.
Hematology · 63d
Cleared Apr 16, 1990
MICRO 2 SYSTEM
K900785 · EGG
Inodent
Dental · 55d
Cleared Apr 16, 1990
WEDJETS
K900844 · EIE
The Hygenic Corp.
Dental · 53d
Cleared Apr 16, 1990
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
K900870 · LJP
Diagnostic Products Corp.
Microbiology · 51d
Cleared Apr 16, 1990
COAG-A-MATE - RA4
K900895 · KQJ
Organon Teknika Corp.
Hematology · 48d
Cleared Apr 16, 1990
COAG-A-MATE - RA4
K900917 · JPA
Organon Teknika Corp.
Hematology · 48d
Cleared Apr 16, 1990
INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
K900974 · JRY
Stellar Bio Systems, Inc.
Microbiology · 45d
Cleared Apr 16, 1990
CHEM-CHEX
K900993 · JJY
Streck Laboratories, Inc.
Chemistry · 45d
Cleared Apr 16, 1990
BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER
K901003 · JJE
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Apr 16, 1990
PULPDENT OIL FREE SURFACE PREPARATION PASTE
K901052 · EJR
Pulpdent Corp.
Dental · 42d
Cleared Apr 16, 1990
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95
K901083 · JGQ
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Apr 16, 1990
DUODERM* CONTROL GEL FORMULA BORDER DRESSING
K901155 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 34d
Cleared Apr 16, 1990
5 STRAIGHT SCISSORS
K901169 · EKJ
American Medical Ceramics, Inc.
Dental · 34d
Cleared Apr 16, 1990
PERIODONTAL KNIFE
K901170 · EKJ
American Medical Ceramics, Inc.
Dental · 34d
Cleared Apr 16, 1990
U-15 SINGLE END SCALER
K901171 · EKJ
American Medical Ceramics, Inc.
Dental · 34d
Cleared Apr 16, 1990
GRACEY CURETTE #13-14
K901172 · EKJ
American Medical Ceramics, Inc.
Dental · 34d
Cleared Apr 16, 1990
DISCOID SPOON EXCAVATOR
K901173 · EKJ
American Medical Ceramics, Inc.
Dental · 34d
Cleared Apr 16, 1990
ELEVATOR #11
K901174 · EKJ
American Medical Ceramics, Inc.
Dental · 34d
Cleared Apr 16, 1990
HAND MIRROR
K901175 · EKJ
American Medical Ceramics, Inc.
Dental · 34d
Cleared Apr 16, 1990
#23 EXPLORER
K901176 · EKJ
American Medical Ceramics, Inc.
Dental · 34d