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
51121–51144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 2010
SONALIS
K100204 · ITX
Smith Associates
Radiology · 25d
Cleared Feb 19, 2010
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
K100209 · FMI
Becton, Dickinson & CO
General Hospital · 25d
Cleared Feb 18, 2010
DIALOG WITH ADIMEA OPTION
K083460 · KDI
B. Braun Avitum AG
Gastroenterology & Urology · 454d
Cleared Feb 18, 2010
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)
K091029 · MCW
Rex Medical
Cardiovascular · 314d
Cleared Feb 18, 2010
HG II SHORT FIXTURE SYSTEM
K091678 · DZE
Osstem Implant Co., Ltd.
Dental · 253d
Cleared Feb 18, 2010
CARRIGEN
K093447 · MQV
Etex Corp.
Orthopedic · 105d
Cleared Feb 18, 2010
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
K093635 · NBW
Taidoc Technology Corporation
Chemistry · 87d
Cleared Feb 18, 2010
LS-40 CO2 LASER SYSTEM MODEL LS-40
K093793 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 70d
Cleared Feb 18, 2010
DURASPAN HEMODIALYSIS LONG-TERM CATHETER
K100169 · MSD
R4 Vascular, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 17, 2010
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
K092028 · HGM
Philips Medizin Systeme Boeblingen GmbH
Obstetrics & Gynecology · 226d
Cleared Feb 17, 2010
THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
K092175 · PDU
Flowcardia, Inc.
Cardiovascular · 211d
Cleared Feb 17, 2010
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
K092227 · HAE
Integra Lifesciences Corp.
Neurology · 209d
Cleared Feb 17, 2010
PDS PLATES
K092590 · NHB
Ethicon, Inc.
Ear, Nose, Throat · 177d
Cleared Feb 17, 2010
TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
K093064 · NEU
Somatex Medical Technologies GmbH
General & Plastic Surgery · 140d
Cleared Feb 17, 2010
XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150,...
K093120 · KDI
Baxter Healthcare Corporation - Renal...
Gastroenterology & Urology · 138d
Cleared Feb 17, 2010
AFM ULTRA AG DRESSINGS
K093188 · FRO
Milliken & Co.
General & Plastic Surgery · 131d
Cleared Feb 17, 2010
REVERE STABILIZATION SYSTEM
K093294 · NKB
Globus Medical, Inc.
Orthopedic · 119d
Cleared Feb 17, 2010
CORE-FLO D/C
K093470 · EBF
Bisco, Inc.
Dental · 103d
Cleared Feb 17, 2010
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0
K093533 · MBH
Materialise NV
Orthopedic · 93d
Cleared Feb 17, 2010
BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
K093650 · DTY
Medtronic, Inc.
Cardiovascular · 84d
Cleared Feb 17, 2010
RACEGEL
K093711 · MVL
Septodont
Dental · 78d
Cleared Feb 17, 2010
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
K093865 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Feb 17, 2010
EDGELOCK
K093900 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 61d
Cleared Feb 17, 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100138 · MNI
Alphatec Spine, Inc.
Orthopedic · 29d