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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
52057–52080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 2009
EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION...
K091140 · FMI
Vidacare Corporation
General Hospital · 177d
Cleared CT Oct 14, 2009
ELECTROFLUIDGRAPH
K091369 · MNW
Akern USA, LLC
Gastroenterology & Urology · 159d
Cleared Oct 14, 2009
FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500
K091420 · ONG
Solta Medical, Inc.
General & Plastic Surgery · 154d
Cleared Oct 14, 2009
HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
K091703 · QEZ
Concentric Medical, Inc.
Cardiovascular · 126d
Cleared Oct 14, 2009
CAD 12, COLONOSCOPY ASSIST DEVICE
K092156 · FED
Softscope Medical Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 14, 2009
RHYTHM OF LIFE, MODEL R0901-05
K092408 · LIX
Rapid Response Solutions, LLC
Cardiovascular · 69d
Cleared Oct 13, 2009
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
K090017 · DQK
Biosense Webster, Inc.
Cardiovascular · 284d
Cleared Oct 13, 2009
DISPOSABLE TPE INFUSION SET
K090459 · FPA
Shan Dong Wei Gao Group Medical...
General Hospital · 232d
Cleared Oct 13, 2009
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
K091709 · FOZ
Edwards Lifesciences, LLC
General Hospital · 125d
Cleared Oct 13, 2009
DISPOSAL ECG ELECTRODES, MODEL EASYRODE
K092389 · DRX
Suzuken Co., Ltd.
Cardiovascular · 69d
Cleared Oct 09, 2009
MAXMORESPINE TOM STICK
K083552 · HRX
Hoogland Spine Products, GmbH
Orthopedic · 312d
Cleared Oct 09, 2009
WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM
K090190 · HAW
Nuclemed S.A.
Neurology · 256d
Cleared Oct 09, 2009
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
K090563 · GGN
Instrumentation Laboratory CO
Hematology · 221d
Cleared Oct 09, 2009
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
K090650 · JOJ
Spsmedical Supply Corp.
General Hospital · 212d
Cleared Oct 09, 2009
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
K090653 · NBW
Arkray Factory USA, Inc.
Chemistry · 212d
Cleared Oct 09, 2009
BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
K090705 · JWH
Ortho Development Corp.
Orthopedic · 206d
Cleared Oct 09, 2009
COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO
K090991 · JAK
E-Woo Technology
Radiology · 185d
Cleared Oct 09, 2009
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216 · JIL
Siemens Healthcare Diagnostics
Chemistry · 165d
Cleared Oct 09, 2009
LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L
K091440 · GEI
Bovie Medical
General & Plastic Surgery · 147d
Cleared Oct 09, 2009
SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK...
K091574 · GAT
Supplidores Unidos Internacionales, S.A.
General & Plastic Surgery · 129d
Cleared Oct 09, 2009
MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
K091584 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 129d
Cleared Oct 09, 2009
LAMINOPLASTY FIXATION SYSTEM
K091623 · NQW
Nuvasive, Inc.
Orthopedic · 128d
Cleared Oct 09, 2009
BD SPINAL NEEDLE 27G
K091758 · BSP
Becton Dickson & Co.
Anesthesiology · 115d
Cleared Oct 09, 2009
3 WAY SILICONE FOLEY BALLOON CATHETER
K091767 · EZL
Cook Urological, Inc.
Gastroenterology & Urology · 114d