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
125473–125496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1990
CIBA CORNING MAGIC LITE LH IMMUNOASSAY
K902398 · CEP
Ciba Corning Diagnostics Corp.
Chemistry · 29d
Cleared Jun 28, 1990
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
K902541 · KTN
Trinity Laboratories, Inc.
Immunology · 22d
Cleared Jun 28, 1990
RAICHEM(TM) SPIA(TM) CRP REAGENT
K902593 · DCN
Reagents Applications, Inc.
Immunology · 16d
Cleared Jun 28, 1990
LIPOGEN RHEUMELISA DSDNA ASSAY
K902636 · LRY
Lipogen, Inc.
Immunology · 14d
Cleared Jun 27, 1990
MAXX 470 CORE BIOPSY GUN
K900082 · KNW
Dlp, Inc.
Gastroenterology & Urology · 173d
Cleared Jun 27, 1990
GAMASHIELD
K900298 · KGO
Formtex Medical Sdn. Bhd.
General Hospital · 155d
Cleared Jun 27, 1990
LYNX LOW-SPEED HANDPIECE
K900798 · EFB
Air Motors Technologies
Dental · 127d
Cleared Jun 27, 1990
EXTERNAL LEG BAG
K901219 · FAQ
Orion Life Systems, Inc.
Gastroenterology & Urology · 106d
Cleared Jun 27, 1990
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
K901482 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 27, 1990
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B
K901493 · GNX
Whittaker Bioproducts, Inc.
Microbiology · 90d
Cleared Jun 27, 1990
VKG 1000, VIDEO KERATOGRAPH
K901523 · HJA
The Sanborn Co.
Ophthalmic · 86d
Cleared Jun 27, 1990
MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33
K901638 · GEX
Lasermatic, Inc.
General & Plastic Surgery · 79d
Cleared Jun 27, 1990
IMPROVED BAKER TWIN-CUFF SUMP TUBE
K901683 · KNT
Bissell Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 27, 1990
LIFESTYLE HOME TANNING UNITS
K901714 · LEJ
Life Products, Inc.
General & Plastic Surgery · 75d
Cleared Jun 27, 1990
SELFCATH
K901738 · KOD
Vitaid, Ltd.
Gastroenterology & Urology · 71d
Cleared Jun 27, 1990
LASEGUIDE CAT # CLF-600D & CLF-1000D
K901786 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 70d
Cleared Jun 27, 1990
DENTIN PROTECTOR
K901915 · LBH
Ivoclar North America, Inc.
Dental · 62d
Cleared Jun 27, 1990
3M LUTING CEMENT - PASTE A AND PASTE B
K902041 · EMA
3M Company
Dental · 54d
Cleared Jun 26, 1990
LIFECARE MICRO PUMP (INFUSION PUMP)
K893769 · FRN
Abbott Laboratories
General Hospital · 403d
Cleared Jun 26, 1990
AUDIOTESTER SCREENING AUDIOMETER
K894484 · EWO
Prometex, Inc.
Ear, Nose, Throat · 343d
Cleared Jun 26, 1990
MD-2 IONTOPHORESIS UNIT
K895365 · EGJ
R. A. Fischer Co. Corp.
Physical Medicine · 302d
Cleared Jun 26, 1990
PANCRETEC I.V. MODEL 5000 INFUSER
K895867 · FRN
Abbott Laboratories
General Hospital · 265d
Cleared Jun 26, 1990
COBAS READY PROFILE 2 REAGENT STRIP
K896225 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 239d
Cleared Jun 26, 1990
INTRAUTERINE INSEMINATION CATHETERS
K896960 · HDR
C.R. Bard, Inc.
Obstetrics & Gynecology · 194d