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
125113–125136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1990
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
K902253 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 66d
Cleared Jul 26, 1990
PALATRAY LC RESIN IMPRESSION TRAY MATERIAL
K902350 · EBH
Kulzer, Inc.
Dental · 62d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL I
K902361 · GGN
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL II
K902362 · GGN
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL III
K902363 · GGN
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 26, 1990
COHERENT XA30/SP AND XA50 SURGICAL LASERS
K902470 · GEX
Lumenis, Inc.
General & Plastic Surgery · 52d
Cleared Jul 26, 1990
VAAKA BABY SCALE
K902545 · FRW
Ferguson Medical
General Hospital · 48d
Cleared Jul 26, 1990
VISI-SWAB OPHTALMIC SPONGE
K902750 · HOZ
Visitec Co.
Ophthalmic · 34d
Cleared Jul 26, 1990
ZENITH HYLO AND VERTI-LIFT CHIROPRACTIC TABLES
K902971 · INQ
Williams Manufacturing Co.
Physical Medicine · 20d
Cleared Jul 25, 1990
MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U
K900170 · JAK
Elscint, Inc.
Radiology · 194d
Cleared Jul 25, 1990
ISOFLO(TM) AMNIOCENTESIS TRAY
K901643 · HIO
Healthdyne Cardiovascular, Inc.
Obstetrics & Gynecology · 107d
Cleared Jul 25, 1990
KODAK M35A-M X-OMAT PROCESSOR
K901772 · IXW
Eastman Kodak Company
Radiology · 97d
Cleared Jul 25, 1990
COMFORTRAC TABLE MODEL CT-1000
K901971 · JFB
Comfortrac Systems
Physical Medicine · 85d
Cleared Jul 25, 1990
DIGITAL MANOMETER (DM 50)
K901998 · BXR
Medical Support Products, Inc.
Anesthesiology · 84d
Cleared Jul 25, 1990
SOEHENDRA LITHOTRIPSY SET
K902170 · LQC
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 72d
Cleared Jul 25, 1990
KRONAMAX HUMAN PERFORMANCE LAB
K902219 · IKK
Physicians Digital Co.
Physical Medicine · 70d
Cleared Jul 25, 1990
HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1
K902664 · IQA
Prentke Romich Co.
Physical Medicine · 37d
Cleared Jul 25, 1990
MODEL 9000 AT ANKLE CPM DEVICE
K902707 · BXB
Sutter Corp.
Physical Medicine · 36d
Cleared Jul 25, 1990
ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS
K902713 · CAC
Diemolding Corp.
Anesthesiology · 35d
Cleared Jul 25, 1990
MODIFIED CHAIRS (DENTAL, MEDICAL, AND PODIATRY)
K902795 · INO
The Healthcare Group, Inc.
Physical Medicine · 29d
Cleared Jul 25, 1990
LIBERTY HOT PACK AND LIBERTY KOLD PACK
K902839 · IMD
Liberty Ent.
Physical Medicine · 27d
Cleared Jul 25, 1990
INFRASSAGE MASSAGER
K902895 · IRT
Conair Corp.
Physical Medicine · 22d
Cleared Jul 25, 1990
SHOWER-A-WAY
K902951 · INN
Tri-S-Sales and Mfg.
Physical Medicine · 20d
Cleared Jul 25, 1990
MINI-VIBRATOR
K903098 · IRO
Frank J. Biehl
Physical Medicine · 12d