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
125665–125688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1990
C.P.R. LANDMARC
K900415 · LIX
Can-Am Medical, Inc.
Cardiovascular · 133d
Cleared Jun 12, 1990
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
K900718 · LCP
Roche Diagnostic Systems, Inc.
Chemistry · 118d
Cleared Jun 12, 1990
TENSOPLUS LITE
K901378 · NAD
Smith & Nephew United, Inc.
General & Plastic Surgery · 82d
Cleared Jun 12, 1990
POWERBASE II (PB2)
K901399 · DQA
Nellcor, Inc.
Anesthesiology · 78d
Cleared Jun 12, 1990
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458
K901402 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 78d
Cleared Jun 12, 1990
REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)
K901463 · JQJ
Helena Laboratories
Chemistry · 76d
Cleared Jun 12, 1990
ABSORBABLE GAUZE DRAPE
K901465 · KKX
Ulti-Med Intl., Inc.
General Hospital · 77d
Cleared Jun 12, 1990
F-20 TOTAL HIP PROSTHESIS
K901480 · JDI
Med-Tek Corp.
Orthopedic · 77d
Cleared Jun 12, 1990
ENZYMATIC THEOPHYLLINE REAGENT, #500-82
K901510 · KLS
Diagnostic Chemicals, Ltd. (Usa)
Toxicology · 74d
Cleared Jun 12, 1990
MODIFIED OPUS PHENOBARBITAL TEST SYSTEM
K901537 · LET
Pb Diagnostic Systems, Inc.
Toxicology · 71d
Cleared Jun 12, 1990
ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE
K901565 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 70d
Cleared Jun 12, 1990
PROLACTIN (LACTOGEN) TEST SYSTEM
K901673 · CFT
Baxter Healthcare Corp
Chemistry · 63d
Cleared Jun 12, 1990
MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
K901858 · CET
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 49d
Cleared Jun 12, 1990
7620 REMOTE CENTRAL STATION REPEATER
K901884 · DXJ
Marquette Electronics, Inc.
Cardiovascular · 47d
Cleared Jun 12, 1990
SORBA MODEL CIC-1000 W/NEW ELECTRODES
K901926 · DXG
Sorba Medical Systems, Inc.
Cardiovascular · 43d
Cleared Jun 12, 1990
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS
K902095 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 35d
Cleared Jun 12, 1990
HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)
K902155 · JIM
Hichem Diagnostics
Chemistry · 28d
Cleared Jun 12, 1990
COULTER SERUM IRON/UIBC REAGENT
K902173 · JIY
Coulter Corp.
Chemistry · 29d
Cleared Jun 12, 1990
COULTER UREA NITROGEN REAGENT
K902175 · CDQ
Coulter Corp.
Chemistry · 29d
Cleared Jun 12, 1990
COULTER DIRECT BILIRUBIN
K902199 · CIG
Coulter Corp.
Chemistry · 27d
Cleared Jun 12, 1990
COULTER CARBON DIOXIDE REAGENT
K902229 · KHS
Coulter Corp.
Chemistry · 26d
Cleared Jun 12, 1990
BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS
K902267 · CHL
Phoenix Diagnostics, Inc.
Chemistry · 22d
Cleared Jun 11, 1990
MEDITHERM
K894152 · IMI
Medical Equipment Designs, Inc.
Physical Medicine · 362d
Cleared Jun 11, 1990
AUSONICS 5000
K896714 · IYO
Ausonics Pty , Ltd.
Radiology · 194d