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
125305–125328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 1990
MERCURY THERMOMETERS (ORAL AND RECTAL)
K900646 · FLK
Abel Industries, Inc.
General Hospital · 152d
Cleared Jul 11, 1990
RATE INFUSER PLUS
K900742 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 145d
Cleared Jul 11, 1990
ADD-A-VIAL II BINARY CONNECTOR
K900865 · LHI
Kendall Mcgaw Laboratories, Inc.
General Hospital · 138d
Cleared Jul 11, 1990
THERMOMETER, MERCURY/CLINICAL
K901790 · FLK
Perlink USA, Inc.
General Hospital · 83d
Cleared Jul 11, 1990
PLASTIC-GUIDES
K901842 · IWJ
M & K Co.
Radiology · 78d
Cleared Jul 11, 1990
WET-NO-MORE MONITOR
K901906 · KPN
Travis Industries, Inc.
Gastroenterology & Urology · 75d
Cleared Jul 11, 1990
MODEL# MPC
K901951 · IZO
Amerisys
Radiology · 71d
Cleared Jul 11, 1990
S.S.C. MEDICAL PRODUCTS HOME HEALTH CARE BED
K902183 · FNL
Super Sagless Corp.
General Hospital · 58d
Cleared Jul 11, 1990
BALDUR LATEX EXAMINATION GLOVES
K902644 · LYY
Hti Trading Group
General Hospital · 26d
Cleared Jul 10, 1990
PROTEIN TEST FOR URINE AND CSF
K900733 · CEK
Elite Technology, Inc.
Chemistry · 144d
Cleared Jul 10, 1990
PHYSICIAN BARRIER GLOVE, SURGICAL
K901221 · LYU
Dynamic Marketing Ent.
General Hospital · 118d
Cleared Jul 10, 1990
CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA.
K901500 · CHJ
Olympus Corp.
Chemistry · 103d
Cleared Jul 10, 1990
MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM
K901613 · CGA
Medisense, Inc.
Chemistry · 95d
Cleared Jul 10, 1990
LITTER, FOLDING RIGID POLE, DECONTAMINABLE
K901760 · FPP
Dept. of the Army
General Hospital · 83d
Cleared Jul 10, 1990
PLEURA BIOPSY DEVICE
K901995 · GDM
Mill-Rose Laboratory
General & Plastic Surgery · 69d
Cleared Jul 10, 1990
TENONE(TM) OPIATES CATALOG: VKSO1,4
K902055 · DDE
Diagnostic Products Corp.
Toxicology · 64d
Cleared Jul 10, 1990
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700
K902061 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 64d
Cleared Jul 10, 1990
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700
K902148 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 56d
Cleared Jul 10, 1990
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
K902483 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 10, 1990
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM
K902536 · JJY
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Jul 10, 1990
STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES
K902567 · JDR
A. Henniss
Orthopedic · 29d
Cleared Jul 10, 1990
SODIUM REAGENT SET
K902572 · CEI
Tech Intl. Co.
Chemistry · 29d
Cleared Jul 10, 1990
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM
K902573 · JJY
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Jul 10, 1990
POTASSIUM REAGENT SET
K902574 · CEJ
Tech-Co, Inc.
Chemistry · 29d