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
137137–137160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1987
COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE
K873605 · LWM
Pain Prevention Laboratory, Inc.
Dental · 117d
Cleared Dec 30, 1987
CTI STRAIGHT STEM
K873627 · JDG
Orthopedic Systems, Inc.
Orthopedic · 113d
Cleared Dec 30, 1987
LAKE IRRIGATION TRAY
K873991 · FMI
Lake Medical Products, Inc.
General Hospital · 90d
Cleared Dec 30, 1987
PRIA-KIT (TM) PRIAPISM KIT S.S.
K874000 · GAA
Canton Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 30, 1987
PHARMASEAL WOUND IRRIGATION DEVICE
K874022 · FQH
American Pharmaseal Div. Ahsc
General Hospital · 89d
Cleared Dec 30, 1987
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
K874032 · CEP
Diagnostic Products Corp.
Chemistry · 89d
Cleared Dec 30, 1987
CHEMO-PORT
K874184 · LJT
Hdc Corp.
General Hospital · 77d
Cleared Dec 30, 1987
DINAMAP VITAL SIGNS MONITOR, MODEL 8100T
K874378 · DXN
Critikon Company, LLC
Cardiovascular · 65d
Cleared Dec 30, 1987
CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE
K874386 · JCN
R&D Systems, Inc.
Hematology · 65d
Cleared Dec 30, 1987
PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE
K874405 · JOD
Pall Biomedical Products Co.
Cardiovascular · 63d
Cleared Dec 30, 1987
TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE)
K874437 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 63d
Cleared Dec 30, 1987
MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)
K874446 · DHB
3M Company
Immunology · 63d
Cleared Dec 30, 1987
MC/CPAP MANIFOLD
K874479 · BYE
Minneapolis Children'S Services Corp.
Anesthesiology · 58d
Cleared Dec 30, 1987
MONAGHAN AEROCHAMBER WITH MASK
K874513 · CCQ
Monaghan Medical Corp.
Anesthesiology · 58d
Cleared Dec 30, 1987
STERILE SURGICAL SCRUB BRUSH
K874653 · GEC
Surgikos, Inc.
General & Plastic Surgery · 47d
Cleared Dec 30, 1987
COLLI-MATETM MODEL NO. B800
K874687 · IZX
Summit Industries, Inc.
Radiology · 47d
Cleared Dec 30, 1987
COLORED CASTING TAPE CARAGLAS(TM GREEN
K874880 · LGF
Synthetic Mfg., Inc.
Orthopedic · 29d
Cleared Dec 30, 1987
ISOLATION GOWN
K874888 · FYC
Sage Products, Inc.
General Hospital · 29d
Cleared Dec 30, 1987
U.V. SUNLAMP 95 UF-11
K874889 · FTC
Light Sources, Inc.
General & Plastic Surgery · 29d
Cleared Dec 30, 1987
WHOLEY (TM) BIOPSY DEVICE
K874928 · GDM
Medrad, Inc.
General & Plastic Surgery · 28d
Cleared Dec 30, 1987
MICROSURGICAL INSTRUMENTS
K874950 · HTD
Solway, Inc.
General & Plastic Surgery · 28d
Cleared Dec 30, 1987
MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES
K874952 · HBG
Solway, Inc.
Neurology · 28d
Cleared Dec 30, 1987
MANUAL RONGEUR
K874954 · HTX
Solway, Inc.
Orthopedic · 28d
Cleared Dec 30, 1987
VASCULAR CLAMP
K874959 · HXD
Solway, Inc.
General & Plastic Surgery · 28d