Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
62545–62568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2006
SOCKET GRAFT
K052493 · LYC
Steiner Laboratories
Dental · 270d
Cleared Jun 09, 2006
DIACAP ULTRA DIALYSIS FLUID FILTER
K052764 · FKQ
B. Braun Medizintechnologie GmbH
Gastroenterology & Urology · 252d
Cleared Jun 09, 2006
UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)
K053172 · MUH
Owandy Sas
Radiology · 207d
Cleared Jun 09, 2006
KOWA KT-800
K053444 · HKX
Kowa Co. , Ltd.
Ophthalmic · 182d
Cleared Jun 09, 2006
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
K060402 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 114d
Cleared Jun 09, 2006
TIPI
K060526 · HHW
Contipi , Ltd.
Obstetrics & Gynecology · 102d
Cleared Jun 09, 2006
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC
K060686 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 86d
Cleared Jun 09, 2006
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
K060766 · DPS
Omron Healthcare, Inc.
Cardiovascular · 79d
Cleared Jun 09, 2006
ONLINE TDM TOBRAMYCIN
K060853 · KLB
Roche Diagnostics Corp.
Toxicology · 72d
Cleared Jun 09, 2006
AS101, BLOOD PRESSURE CUFF
K060871 · DXQ
Wenzhou Longwan Medical Instrument...
Cardiovascular · 71d
Cleared Jun 09, 2006
MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
K060896 · DJC
Varian, Inc.
Toxicology · 67d
Cleared Jun 09, 2006
TRIDENT ANCHOR
K060914 · HWC
Johnson & Johnson Company
Orthopedic · 66d
Cleared Jun 09, 2006
GENESIS OTC MONITOR
K061087 · DRG
Honeywell Hommed, LLC
Cardiovascular · 52d
Cleared Jun 09, 2006
SENTRY OTC MONITOR
K061088 · DRG
Honeywell Hommed, LLC
Cardiovascular · 52d
Cleared Jun 09, 2006
M-VU CAD STATION
K061160 · LLZ
Vucomp, Inc.
Radiology · 44d
Cleared Jun 09, 2006
CPIVISION DIGITAL IMAGING SYSTEM
K061173 · OWB
Communications & Power Industries...
Radiology · 43d
Cleared Jun 09, 2006
GALILEOS IMPLANT, V 1.0
K061472 · LLZ
Sicat GmbH & Co. KG
Radiology · 10d
Cleared Jun 08, 2006
DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS
K060098 · NUC
Ssl Americas, Inc.
Obstetrics & Gynecology · 146d
Cleared Jun 08, 2006
SSP PEDICLE SCREW SYSTEM
K060118 · MNH
Specialty Spine Products, LLC
Orthopedic · 142d
Cleared Jun 08, 2006
DERMATECH IV HOLDER
K060488 · FPA
Dermatech Medical, Inc.
General Hospital · 104d
Cleared Jun 08, 2006
EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND...
K060537 · LGZ
Enginivity, LLC
General Hospital · 100d
Cleared Jun 08, 2006
LATEX POWDERED EXAMINATION GLOVE
K060858 · LYY
High Momentum Sdn Bhd
General Hospital · 71d
Cleared Jun 08, 2006
ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.
K060916 · MQP
Spinal Edge, LLC
Orthopedic · 65d
Cleared Jun 08, 2006
EBI ESL PEEK-OPTIMA SPINE SYSTEM
K061016 · MQP
Ebi, L.P.
Orthopedic · 56d