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
126337–126360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1990
KEMBLE LIQUID HANDLING SYSTEM DISPENSER
K896684 · JQW
Schiff & Co.
Chemistry · 139d
Cleared Apr 16, 1990
WILSON-COOK LUNG BIOPSY NEEDLE
K897050 · GAA
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 119d
Cleared Apr 16, 1990
MODIFIED PGL ABSORBABLE STAPLE*
K900069 · GDG
United States Surgical, A Division of...
General & Plastic Surgery · 102d
Cleared Apr 16, 1990
CL-OPE CONTACT LASER SYSTEM
K900128 · GEX
Lca, Inc.
General & Plastic Surgery · 97d
Cleared Apr 16, 1990
EXACT ONE(TM) HEMATOLOGY ANALYZER
K900276 · GKZ
Exact Science, Inc.
Hematology · 87d
Cleared Apr 16, 1990
MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES
K900316 · HDR
Irvine Scientific
Obstetrics & Gynecology · 83d
Cleared Apr 16, 1990
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
K900333 · LKD
Radiometer America, Inc.
Anesthesiology · 83d
Cleared Apr 16, 1990
TOXO IGG ELISA TEST
K900354 · LGD
Gull Laboratories, Inc.
Microbiology · 81d
Cleared Apr 16, 1990
ONE/CIRC (CIRCUMCISION CLAMP)
K900370 · HFX
Bionix Development Corp.
Obstetrics & Gynecology · 81d
Cleared Apr 16, 1990
OPAQUE PORCELAIN
K900393 · EIH
Dentsply Intl.
Dental · 77d
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