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
136705–136728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1988
UREA NITROGEN (BUN)
K880078 · CDQ
Tech-Neal Scientific, Inc.
Chemistry · 31d
Cleared Feb 11, 1988
FINNIGAN MAT TSQ-70
K880089 · DOP
Finnigan Corp.
Chemistry · 30d
Cleared Feb 11, 1988
REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY
K880181 · CAZ
Reganes, Inc.
Anesthesiology · 27d
Cleared Feb 11, 1988
MALLEABLE PTFE COATED BRAIN SPATULAE
K880278 · HAO
Downs Surgical , Ltd.
Neurology · 20d
Cleared Feb 10, 1988
COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
K874873 · DHN
Diagnostic Products Corp.
Immunology · 72d
Cleared Feb 10, 1988
LIPOGEN ANA TEST KIT
K875246 · LJM
Lipogen, Inc.
Immunology · 50d
Cleared Feb 10, 1988
QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK
K875281 · DEM
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 48d
Cleared Feb 10, 1988
QM2/QM300 CONTROL B PACK
K875283 · DEM
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 48d
Cleared Feb 10, 1988
IMMUNOGLOBULIN G & G SUBCLASSES
K875356 · DEW
Birmingham
Immunology · 41d
Cleared Feb 10, 1988
INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST
K880148 · KTN
Ampcor, Inc.
Immunology · 28d
Cleared Feb 10, 1988
RF CARD TEST & RF LIQUID TEST
K880164 · DHR
Ampcor, Inc.
Immunology · 28d
Cleared Feb 10, 1988
GEMINI SURGICAL LIGHT
K880198 · FSS
American Sterilizer Co.
General & Plastic Surgery · 26d
Cleared Feb 10, 1988
SURGICAL BLADES
K880244 · GES
Ailee C/O Havel'S, Inc.
General & Plastic Surgery · 21d
Cleared Feb 10, 1988
THERMAL-PAK MODEL SW 1000
K880252 · LHC
Micro Tek Engineering
General Hospital · 21d
Cleared Feb 09, 1988
CARE TELSTAT MODELS: MP 5010 AND MP 5020
K874844 · DRT
Care Systems, Inc.
Cardiovascular · 77d
Cleared Feb 09, 1988
CALIBRATION REFERENCE PLASMA
K874940 · GGP
Baxter Healthcare Corp
Hematology · 69d
Cleared Feb 09, 1988
OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE
K875197 · LRX
Pro-Optics, Inc.
Ophthalmic · 54d
Cleared Feb 09, 1988
RETICULOCYTE STAIN
K875310 · KFC
Sigma Diagnostics, Inc.
Pathology · 42d
Cleared Feb 09, 1988
FIBRINOSTICON
K880077 · GHH
Organon Teknika Corp.
Hematology · 29d
Cleared Feb 08, 1988
5 MHZ DOPPLER OUTRIGGER
K872817 · IYN
Philips Ultrasound, Inc.
Radiology · 207d
Cleared Feb 08, 1988
STARKEY MODEL P1 MODULE
K873031 · LRB
Starkey Laboratories, Inc.
Ear, Nose, Throat · 188d
Cleared Feb 08, 1988
KODAK SURECELL(TM) HCG-URINE KIT
K874388 · JHI
Eastman Kodak Company
Chemistry · 104d
Cleared Feb 08, 1988
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
K874690 · FFX
Mentor Corp.
Gastroenterology & Urology · 84d
Cleared Feb 08, 1988
DIAMOND MEDICAL, INC. MODEL DM 800
K874709 · FFT
Diamond Medical, Inc.
Gastroenterology & Urology · 88d