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
122833–122856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 1991
ANTICARDIOLIPIN ANTIBODY TEST SYSTEM
K903531 · GFO
Medical Innovations Corp.
Immunology · 172d
Cleared Jan 25, 1991
RHEUMAGEN ASO T-CONTROL
K904311 · GTQ
Biokit USA, Inc.
Microbiology · 128d
Cleared Jan 25, 1991
COAG-1 PT-NC TEST CARD
K904325 · GJS
Cardiovascular Diagnostic Services
Hematology · 127d
Cleared Jan 25, 1991
PREMIER-CRYPTOCOCCAL ANTIGEN
K904393 · MDU
Meridian Diagnostics, Inc.
Microbiology · 122d
Cleared Jan 25, 1991
QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
K904603 · CEK
Quantitative Medicine, Inc.
Chemistry · 107d
Cleared Jan 25, 1991
DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555
K904850 · EFS
Micro Motors, Inc.
Dental · 88d
Cleared Jan 25, 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 88d
Cleared Jan 25, 1991
DISPOSABLE FIBER OPTIC DELIVERY SYSTEM
K904911 · GEX
Fiber Delivery Concepts, Inc.
General & Plastic Surgery · 86d
Cleared Jan 25, 1991
BIPOLAR BIOPSY FORCEPS
K904985 · KGE
Everest Medical Corp.
Gastroenterology & Urology · 84d
Cleared Jan 25, 1991
LAPAROSCOPIC ELECTROSURGICAL DEVICE
K904993 · GEI
Everest Medical Corp.
General & Plastic Surgery · 79d
Cleared Jan 25, 1991
FEEL FRESH TOOTHBRUSH KIT
K905090 · EFW
Fresh Appeal , Ltd.
Dental · 72d
Cleared Jan 25, 1991
DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES
K905111 · JAA
Eigen
Radiology · 73d
Cleared Jan 25, 1991
MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE
K905124 · GCT
Red Wing Imaging, Inc.
Gastroenterology & Urology · 72d
Cleared Jan 25, 1991
VANCOMYCIN DISK-5 MCG
K905151 · JTO
Remel Co.
Microbiology · 71d
Cleared Jan 25, 1991
NEUROMED MODEL 1992 LS LAMITRODE LEAD
K905255 · GZB
Neuromed, Inc.
Neurology · 65d
Cleared Jan 25, 1991
ADSON-BECKMAN RETRACTOR, SPINAL
K905445 · GZT
A. Henniss
Neurology · 52d
Cleared Jan 25, 1991
IMMUNOWELL THYROGLOBULIN TEST
K905485 · JZO
General Biometrics, Inc.
Immunology · 50d
Cleared Jan 25, 1991
LUPUS(LE)-LATEX TEST
K905531 · LKI
Immco Diagnostics, Inc.
Immunology · 46d
Cleared Jan 25, 1991
COLUMNS LIQUID CHROMATOGRAPHY DPM
K905538 · KZR
Millpore Corp.
Chemistry · 45d
Cleared Jan 25, 1991
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
K905660 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 25, 1991
AIA-PACK HGH
K905757 · CFL
Tosoh Medics, Inc.
Chemistry · 29d
Cleared Jan 25, 1991
COULTER DART ALT (GPT) REAGENT
K905767 · CKA
Coulter Electronics, Inc.
Chemistry · 29d
Cleared Jan 25, 1991
UBI MAGIWEL(TM) ANA QUANTITATIVE
K910033 · LJM
United Biotech, Inc.
Immunology · 21d
Cleared Jan 24, 1991
EUB-565 DIAGNOSTIC ULTRASOUND DEVICE
K896100 · IYO
Hitachi Medical Corp. of America
Radiology · 461d