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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
115153–115176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1992
MTV-250A, MTV-300A
K924478 · LMA
Toshiba America Medical Systems, In.C
Radiology · 92d
Cleared Dec 03, 1992
SAM LS
K913095 · CAF
Ferguson Medical
Anesthesiology · 510d
Cleared Dec 03, 1992
SAM SC
K913096 · CAF
Ferguson Medical
Anesthesiology · 510d
Cleared Dec 03, 1992
ARBOVIRUS IGG IFA TEST
K913617 · GQC
Hillcrest Biologicals
Microbiology · 478d
Cleared Dec 03, 1992
ARBOVIRUS IGM IFA TEST
K913618 · GQC
Hillcrest Biologicals
Microbiology · 478d
Cleared Dec 03, 1992
DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
K914119 · CAC
Davol, Inc.
Anesthesiology · 447d
Cleared Dec 03, 1992
CEREBROVASCULAR DIAGNOSTIC SYSTEM
K914862 · IYN
Medasonics, Inc.
Radiology · 401d
Cleared Dec 03, 1992
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
K915736 · DTB
Medtronic Vascular
Cardiovascular · 349d
Cleared Dec 03, 1992
TENS MODEL 240Z
K920266 · GZJ
Oms Medical Supplies, Inc.
Neurology · 317d
Cleared Dec 03, 1992
DISPOSABLE CURETTE
K921022 · MDM
Dermtec, Inc.
General & Plastic Surgery · 275d
Cleared Dec 03, 1992
BLUE MAX II BALLOON DDILATATION CATHETER
K921254 · LIT
Boston Scientific Corp
Cardiovascular · 262d
Cleared Dec 03, 1992
KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH
K922113 · BSO
Kendall Healthcare Products Co....
Anesthesiology · 212d
Cleared Dec 03, 1992
COBE SAMPLING SITE
K922484 · DQO
Cobe Cardiovascular, Inc.
Cardiovascular · 190d
Cleared Dec 03, 1992
DEGUCAST 40
K922790 · EJH
Degussa AG
Dental · 177d
Cleared Dec 03, 1992
SPECTRAL EEG MONITOR MODEL A1000
K923043 · OLT
Aspect Medical Systems, Inc.
Neurology · 162d
Cleared Dec 03, 1992
MALE EXTERNAL CATHETER
K923136 · EXJ
Rochester Medical Corp.
Gastroenterology & Urology · 157d
Cleared Dec 03, 1992
ORTHODONTIC METAL BRACKET
K923261 · EJF
American Orthodontics
Dental · 154d
Cleared Dec 03, 1992
CONVEX AND LINEAR ARRAY TRANSDUCERS
K923269 · IYO
Aloka Co., Ltd.
Radiology · 150d
Cleared Dec 03, 1992
FIAGEN PROGESTERONE
K923410 · JLS
Cyberfluor, Inc.
Hematology · 146d
Cleared Dec 03, 1992
ALKALINE PHOSPHATASE KIT
K923507 · CJE
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Dec 03, 1992
GAMMA-GT
K923509 · JPZ
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Dec 03, 1992
ONE TOUCH TEST STRIPS
K923544 · CGA
Lifescan, Inc.
Chemistry · 140d
Cleared Dec 03, 1992
API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC
K923684 · JWY
Analytical Products, Inc.
Microbiology · 133d
Cleared Dec 03, 1992
SYNERMED ENZYMATIC CO2 REAGENT KIT
K924428 · KHS
Synermed, Inc.
Chemistry · 93d