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
55729–55752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 2008
G-IVF G5 SERIES
K081116 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 137d
Cleared Sep 02, 2008
ANTEGRA-T
K081568 · KWQ
Synthes Spine Co.Lp
Orthopedic · 90d
Cleared Sep 02, 2008
HU/HS/HG PROSTHETIC SYSTEM
K081575 · NHA
Osstem Implant Co., Ltd.
Dental · 89d
Cleared Sep 02, 2008
D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)
K081821 · MMK
Global Pathogen Solutions, Inc.
General Hospital · 67d
Cleared Sep 02, 2008
SNAPSHOT
K081925 · MUH
Instrumentarium Dental, Palodex Group OY
Radiology · 57d
Cleared Sep 02, 2008
OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
K082022 · JWH
Exactech, Inc.
Orthopedic · 48d
Cleared Sep 02, 2008
BT3/6, BT12
K082077 · DXH
Corscience GmbH & Co. KG
Cardiovascular · 41d
Cleared Sep 02, 2008
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 /...
K082104 · JAK
Ge Medical Systems, Inc.
Radiology · 39d
Cleared Sep 02, 2008
VIVID I AND VIVID Q
K082374 · IYN
Ge Medical Systems Israel,...
Radiology · 15d
Cleared Aug 29, 2008
PERIMETRICS PERIOMETER
K072213 · EKX
Perimetrics, Inc.
Dental · 386d
Cleared Aug 29, 2008
OTA COLLAGEN BIOMATERIAL
K073685 · NPL
Osseous Technologies of America
Dental · 245d
Cleared Aug 29, 2008
STEREOS WORKSTATION
K080529 · LLZ
Biospace Med
Radiology · 185d
Cleared Aug 29, 2008
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
K080546 · OLT
Nihon Kohden America, Inc.
Neurology · 183d
Cleared Aug 29, 2008
COMBOCARE 2000
K081141 · GZJ
Xanacare Technologies, LLC
Neurology · 129d
Cleared Aug 29, 2008
HEALOS II BONE GRAFT SUBSTITUTE
K081432 · LYC
Depuy Spine, Inc.
Dental · 100d
Cleared Aug 29, 2008
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
K081610 · GKZ
Sysmex America, Inc.
Hematology · 81d
Cleared Aug 29, 2008
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
K081622 · JDQ
Abbott Spine, Inc.
Orthopedic · 80d
Cleared Aug 29, 2008
PLANMECA SOVEREIGN
K081699 · EIA
Planmeca USA, Inc.
Dental · 73d
Cleared Aug 29, 2008
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE,...
K081731 · CGS
Siemens Healthcare Diagnostics
Chemistry · 71d
Cleared Aug 29, 2008
GE DATEX-OHMEDA AVANCE
K081844 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 60d
Cleared Aug 29, 2008
LUTE-IT II VENEER CEMENT, MODEL NO6
K081887 · EMA
Pentron Clinical Technologies
Dental · 58d
Cleared Aug 29, 2008
FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR
K081891 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 58d
Cleared Aug 29, 2008
EXTREMITY MEDICAL COMPRESSION SCREW
K081934 · HWC
Extremity Medical, LLC
Orthopedic · 53d
Cleared Aug 29, 2008
PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE...
K081937 · DQA
Philips Medizin Systeme Boeblingen GmbH
Anesthesiology · 53d