FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126241–126264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1990
BARTON-MAYO TRACHEOSTOMA BUTTON
K901377 · KAC
Medical Innovations International, Inc.
Ear, Nose, Throat · 84d
Cleared Jun 14, 1990
RETRAX SAFETY SYRINGE
K901508 · FMF
Retrax, Inc.
General Hospital · 76d
Cleared Jun 14, 1990
LEG EEZE
K901931 · IRO
Jereva, Inc.
Physical Medicine · 45d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODELS C AND M
K902351 · ESD
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODEL: H
K902352 · ESD
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODELS F AND L
K902353 · ESD
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared Jun 14, 1990
CARDIOTHORACIC RULER
K902378 · KPR
Devcom, Inc.
Radiology · 16d
Cleared Jun 13, 1990
MODULAR FLEXIBLE DRILLING SYSTEM
K901165 · HWE
Dalton Technology, Inc.
Orthopedic · 92d
Cleared Jun 13, 1990
DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER
K901166 · HXX
Dalton Technology, Inc.
Orthopedic · 92d
Cleared Jun 13, 1990
TITAN APOLLO AND NOVA ADJUSTING TABLES
K902234 · INQ
Titan Tables
Physical Medicine · 27d
Cleared Jun 13, 1990
TITAN GLADIATOR ADJUSTING TABLE
K902549 · INQ
Titan Tables
Physical Medicine · 5d
Cleared Jun 12, 1990
AP900/PRP MODULE AND ACCESSORIES, MODIFICATION
K893218 · CAC
Electromedics, Inc.
Anesthesiology · 411d
Cleared Jun 12, 1990
SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM
K896467 · CHH
Medisense, Inc.
Chemistry · 211d
Cleared Jun 12, 1990
ACS ADVANCED CONCEPT GUIDE WIRE
K900386 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 134d
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