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
66817–66840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2005
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)
K050257 · DZE
Mondeal Medical Systems GmbH
Dental · 4d
Cleared Feb 04, 2005
ZOLL AED PRO EXTERNAL DEFIBRILLATOR
K041892 · MKJ
ZOLL Medical Corporation
Cardiovascular · 206d
Cleared Feb 04, 2005
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
K043219 · EWO
Interacoustics AS
Ear, Nose, Throat · 74d
Cleared Feb 04, 2005
EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
K043446 · FOZ
Emmebi Srl
General Hospital · 52d
Cleared Feb 04, 2005
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K043499 · LYZ
Shijaizhuang Brilliant Ocean Plastic...
General Hospital · 49d
Cleared Feb 04, 2005
INSCOPE 3-STAGE BALLOON DILATOR
K043605 · KNQ
Cordis Europa, N.V.
Gastroenterology & Urology · 36d
Cleared Feb 04, 2005
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
K050055 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 24d
Cleared Feb 03, 2005
MEDCOMP SPLIT-CATH II
K040318 · MSD
Medcomp
Gastroenterology & Urology · 360d
Cleared Feb 03, 2005
FOOTHILLS SURGICAL DRAPES
K041224 · KKX
Foothills Industries, Inc.
General Hospital · 269d
Cleared Feb 03, 2005
HOME HEALTH POWER WHEELCHAIR, MODEL HC-200
K042719 · ITI
Home Health Technology Co., Ltd.
Physical Medicine · 126d
Cleared Feb 03, 2005
NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
K042780 · FAJ
Prosurg, Inc.
Gastroenterology & Urology · 120d
Cleared Feb 03, 2005
PIONEER ANTERIOR CERVICAL PLATE SYSTEM
K043066 · KWQ
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Feb 03, 2005
ASSIST HEADER CLEANER
K043126 · LIF
Alcavis International, Inc.
Gastroenterology & Urology · 83d
Cleared Feb 03, 2005
SYNTHES 3.5MM CORTEX SCREWS
K043185 · HWC
Synthes (Usa)
Orthopedic · 78d
Cleared Feb 03, 2005
SIGN FIN NAIL
K043200 · HSB
Surgical Implant Generation Network...
Orthopedic · 77d
Cleared Feb 03, 2005
REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM
K043257 · DRF
Ep Technologies, Inc.
Cardiovascular · 71d
Cleared Feb 03, 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043321 · NKB
Medtronic Sofamor Danek
Orthopedic · 63d
Cleared Feb 03, 2005
BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
K043371 · KRD
Biomerix Corporation
Cardiovascular · 57d
Cleared Feb 03, 2005
SYNGO INSPACE 4D
K043469 · JAK
Siemens AG Medical Solutions
Radiology · 49d
Cleared Feb 03, 2005
TRANSMITTER, ZS-940PA SERIES
K043517 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 45d
Cleared Feb 03, 2005
MODIFIED ACUMEN SHEATH, MODEL TTWO767
K050015 · DYB
Acumen Medical, Inc.
Cardiovascular · 30d
Cleared Feb 03, 2005
NANOSS BONE VOID FILLER
K050025 · MQV
Angstrom Medica, Inc.
Orthopedic · 28d
Cleared Feb 03, 2005
G-LIGHT
K050059 · EBZ
GC America, Inc.
Dental · 23d
Cleared Feb 03, 2005
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
K050147 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 10d