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
135577–135600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1988
EXTENDED LIFE INJECTION SITE
K882007 · FPA
Baxter Healthcare Corp
General Hospital · 38d
Cleared Jun 20, 1988
SHARPLAN MEDILAS 4060 N
K882037 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 35d
Cleared Jun 20, 1988
C-FLO SUCTION TUBE
K882121 · DXQ
Concept, Inc.
Cardiovascular · 32d
Cleared Jun 20, 1988
HELENA REP GEL PROCESSOR
K882163 · JJN
Helena Laboratories
Chemistry · 27d
Cleared Jun 20, 1988
LANDMARK(TM) VENOUS ACCESS DEVICE
K882242 · FOZ
Menlo Care, Inc.
General Hospital · 31d
Cleared Jun 20, 1988
RETROFIT BABY FACE SHIELD (RFS)
K882291 · LBI
Physician Engineered Products, Inc.
General Hospital · 19d
Cleared Jun 17, 1988
MODIFIED COPE SUTURE ANCHOR
K873606 · FGE
Cook, Inc.
Gastroenterology & Urology · 283d
Cleared Jun 17, 1988
PXS MODEL PXS7-730EA DENTAL X-RAY SOURCE
K875212 · EHD
Kevex Corp.
Radiology · 182d
Cleared Jun 17, 1988
DUET (CONDOMS)
K880185 · HIS
American Laboratories, Inc.
Obstetrics & Gynecology · 154d
Cleared Jun 17, 1988
DUNFORD SURGEON'S STERILE GLOVES
K880480 · KGO
Phillippine Radiant C/O U.S. Polymer...
General Hospital · 134d
Cleared Jun 17, 1988
MDL-1 LASERTRIPTER
K880503 · FFK
Candela Laser Corp.
Gastroenterology & Urology · 130d
Cleared Jun 17, 1988
MCT MEDICAL BROWNE UROSCAN URODYNAMIC
K880504 · EXY
Mct Medical, Inc.
Gastroenterology & Urology · 133d
Cleared Jun 17, 1988
PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE
K881252 · GCX
Deknatel, Inc.
General Hospital · 86d
Cleared Jun 17, 1988
PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
K881378 · LXI
Pfizer, Inc.
Orthopedic · 77d
Cleared Jun 17, 1988
MODEL BIOSTAR
K882062 · HCC
Targus Concepts
Neurology · 32d
Cleared Jun 17, 1988
SPINAL DISTRACTORS, SPANNERS
K882069 · LXH
Karlin Technology, Inc.
Orthopedic · 31d
Cleared Jun 17, 1988
ORTHOPAEDIC AND SPINAL RING CURRETTES
K882072 · JXH
Karlin Technology, Inc.
Neurology · 31d
Cleared Jun 17, 1988
MICRODISCECTOMY CURRETTES
K882077 · LXH
Karlin Technology, Inc.
Orthopedic · 31d
Cleared Jun 17, 1988
SURGICAL DUCT CLAMP (VINE)
K882169 · GDJ
Henley Intl.
General & Plastic Surgery · 24d
Cleared Jun 17, 1988
RX ASPEN
K882170 · EJH
Jeneric/Pentron, Inc.
Dental · 24d
Cleared Jun 17, 1988
NEOTECH UNIVERSAL ADAPTER
K882203 · BZA
Neotech Products, Inc.
Anesthesiology · 23d
Cleared Jun 17, 1988
1/2 CM REAR TIP EXTENDER (RTE)
K882297 · FHN
American Medical Systems, Inc.
Gastroenterology & Urology · 15d
Cleared Jun 16, 1988
ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201
K874366 · DTB
Cordis Leads, Inc.
Cardiovascular · 237d
Cleared Jun 16, 1988
WITT BIOMEDICAL VX-80
K880258 · DXG
Witt Biomedical Corporation
Cardiovascular · 146d