FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
42793–42816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2012
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL...
K121383 · FJS
Medical Components, Inc.
Gastroenterology & Urology · 120d
Cleared Sep 05, 2012
MOLLRING MULTITASC
K121415 · DWX
LeMaitre Vascular, Inc.
Cardiovascular · 117d
Cleared Sep 05, 2012
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK...
K121654 · CGA
I-Sens, Inc.
Chemistry · 92d
Cleared Sep 05, 2012
BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
K121787 · DZE
BioHorizons Implant Systems, Inc.
Dental · 79d
Cleared Sep 05, 2012
STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM
K121893 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 68d
Cleared Sep 05, 2012
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
K122030 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 56d
Cleared Sep 05, 2012
RELIANCE ANTERIOR CERVICAL PLATE SYSTEM
K122216 · KWQ
Reliance Medical Systems, LLC
Orthopedic · 42d
Cleared Sep 05, 2012
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON...
K122379 · LIT
Ostial Corporation
Cardiovascular · 30d
Cleared Sep 05, 2012
TERUMO SURFLASH SAFETY I.V. CATHETER
K122544 · FOZ
Terumo Corporation
General Hospital · 15d
Cleared Sep 05, 2012
UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM
K122583 · IYN
Samsung Medison Co., Ltd.
Radiology · 12d
Cleared Sep 04, 2012
TENS BACK PAIN RELIEF SYSTEM
K113321 · NUH
Savia Limited
Neurology · 299d
Cleared Sep 04, 2012
ORTHOFIX GALAXY FIXATION SYSTEM
K113770 · KTT
Orthofix Srl
Orthopedic · 257d
Cleared Sep 04, 2012
CVINSIGHT
K120052 · DQA
Intelomed, Inc.
Anesthesiology · 242d
Cleared Sep 04, 2012
IOI TOTAL HIP
K121034 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 152d
Cleared Sep 04, 2012
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
K122042 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 54d
Cleared Sep 04, 2012
ALAMO P
K122047 · MAX
Alliance Partners, LLC
Orthopedic · 54d
Cleared Sep 04, 2012
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE...
K122155 · MUH
VATECH Co., Ltd.
Radiology · 46d
Cleared Sep 04, 2012
ARC ENDOCUFF
K122565 · FED
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 13d
Cleared Aug 31, 2012
DACRYOCATH
K113508 · OKS
Armadillo Biomedical, LLC
Ophthalmic · 277d
Cleared Aug 31, 2012
PINTLER PATIENT WARMING SYSTEM
K113705 · DWJ
Pintler Medical
Cardiovascular · 259d
Cleared Aug 31, 2012
STALIF C
K120819 · OVE
Centinel Spine, Inc.
Orthopedic · 165d
Cleared Aug 31, 2012
FLEXLAB 3.6, ACCELERATOR A3600
K121012 · CEM
Inpeco S.P.A.
Chemistry · 150d
Cleared Aug 31, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
K121196 · LOX
Boston Scientific Corp
Cardiovascular · 134d
Cleared Aug 31, 2012
DISPOSABLE HEMOSTASIS CHIP
K121505 · PKL
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 102d