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
82225–82248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2000
2.4MM CORTEX SCREW, SELF-TAPPING
K002271 · HWC
Synthes (Usa)
Orthopedic · 30d
Cleared Aug 25, 2000
FRESENIUS OPTIFLUX 200NR
K002277 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Aug 25, 2000
WIZAIR COMPRESSION SYSTEM
K002287 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 29d
Cleared Aug 25, 2000
MODEL 9000 BARIATRIC WHEELCHAIR
K002317 · IOR
Invacare Corp.
Physical Medicine · 25d
Cleared Aug 25, 2000
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
K002365 · DYB
Datascope Corp.
Cardiovascular · 22d
Cleared Aug 25, 2000
EHC500 DESKTOP PATIENT STATION, MODEL EHC500
K002388 · DXN
Cybercare, Inc.
Cardiovascular · 21d
Cleared Aug 25, 2000
COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS
K002491 · IYN
Medison Co., Ltd.
Radiology · 11d
Cleared Aug 25, 2000
AERONEB II, MODEL APN 200
K992831 · CAF
Aerogen, Inc.
Anesthesiology · 368d
Cleared Aug 25, 2000
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
K994198 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 256d
Cleared Aug 24, 2000
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
K000158 · GEX
Fisma, Inc.
General & Plastic Surgery · 218d
Cleared Aug 24, 2000
VAPOTHERM, MODEL 2000I
K000401 · BTT
Vapotherm, Inc.
Anesthesiology · 199d
Cleared Aug 24, 2000
CHROMOSTREAK
K000718 · JSN
Novamed , Ltd.
Microbiology · 174d
Cleared Aug 24, 2000
ODONTOSURGE 3
K001560 · EKZ
Odonto-Wave
Dental · 97d
Cleared Aug 24, 2000
LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 &...
K001633 · MSD
Vasca, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 24, 2000
C-REACTIVE PROTEIN ANTISERUM KIT
K001636 · DCK
The Binding Site, Ltd.
Immunology · 86d
Cleared Aug 24, 2000
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K001666 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 24, 2000
SYNTHES SACRAL BAR SYSTEM
K001720 · JDW
Synthes (Usa)
Orthopedic · 79d
Cleared Aug 24, 2000
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
K001759 · JDI
Implex Corp.
Orthopedic · 76d
Cleared Aug 24, 2000
ANTERIOR CERVICAL PLATE SYSTEM
K001847 · KWQ
Encore Orthopedics, Inc.
Orthopedic · 66d
Cleared Aug 24, 2000
HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
K002021 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 52d
Cleared Aug 24, 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K002206 · DQX
Guidant Corp.
Cardiovascular · 34d
Cleared Aug 24, 2000
SUPER 1
K002298 · EJH
Dental Alloy Products, Inc.
Dental · 27d
Cleared Aug 24, 2000
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
K002324 · JDI
Sulzermedica
Orthopedic · 24d
Cleared Aug 24, 2000
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
K002435 · GAW
Axya Medical, Inc.
General & Plastic Surgery · 15d