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
43945–43968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 2012
PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
K120341 · JAQ
Varian Medical Systems, Inc.
Radiology · 84d
Cleared Apr 27, 2012
VOLUSON S6, VOLUSON S8
K120741 · IYN
Ge Healthcare
Radiology · 46d
Cleared Apr 27, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K120746 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 46d
Cleared Apr 27, 2012
EPIFLO(R)
K120764 · KPJ
Neogenix, LLC
General & Plastic Surgery · 45d
Cleared Apr 27, 2012
SECURACATH
K120935 · OKC
Interrad Medical, Inc.
General Hospital · 30d
Cleared Apr 27, 2012
PATHASSIST LIGHT FIBER
K120962 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 28d
Cleared Apr 27, 2012
TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR...
K121106 · DWL
Surgical Appliance Industries, Inc.
General Hospital · 15d
Cleared Apr 26, 2012
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K110835 · LPL
GEO MEDICAL CO., LTD.
Ophthalmic · 398d
Cleared Apr 26, 2012
IROOT 100 MINI
K112153 · LQY
S-Denti Co., Ltd.
Dental · 294d
Cleared Apr 26, 2012
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
K112342 · KNT
Convatec, Inc.
Gastroenterology & Urology · 255d
Cleared Apr 26, 2012
SOLITAIRE-C CERVICAL SPACER SYSTEM
K113796 · OVE
Ebi, LLC
Orthopedic · 125d
Cleared Apr 26, 2012
TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM
K120437 · GEX
Biolitec Sia (Latvia)
General & Plastic Surgery · 73d
Cleared Apr 26, 2012
DEPUY PULSE CERVICAL CAGE SYSTEM
K120517 · ODP
Medos International SARL
Orthopedic · 65d
Cleared Apr 26, 2012
AERONEB PRO
K120939 · CAF
Aerogen, Ltd.
Anesthesiology · 28d
Cleared Apr 26, 2012
C-QUR RPM MESH
K121070 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 17d
Cleared Apr 25, 2012
SHARPS TANK REUSABLE SHARPS CONTAINER
K111085 · MMK
Rehrig Pacific Company
General Hospital · 372d
Cleared Apr 25, 2012
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
K112611 · MNI
Sintea Plastek, LLC
Orthopedic · 231d
Cleared Apr 25, 2012
ZOLL PROPAQ MD
K112761 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 216d
Cleared Apr 25, 2012
ELECTROCARDIOGRAPH
K113485 · DPS
Shenzhen Carewell Electronics Co., Ltd.
Cardiovascular · 154d
Cleared Apr 25, 2012
NASAL/EPISTAXIS PACK
K113585 · LYA
Cogent Therapeutics, LLC
Ear, Nose, Throat · 142d
Cleared Apr 25, 2012
VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX...
K113760 · HRS
Howmedica Osteonics Corp., Dba...
Orthopedic · 126d
Cleared Apr 25, 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
K120908 · HCG
MicroVention, Inc.
Neurology · 30d
Cleared Apr 25, 2012
CAREFUSION NICOLET EDX
K120979 · GWF
Carefusion 209, Inc.
Neurology · 23d
Cleared Apr 24, 2012
AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
K103230 · CGA
Bestgen Biotech Corp.
Chemistry · 540d