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

Filters: Cleared only ×
175,820 results
52177–52200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2009
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE...
K090557 · NSI
Given Imaging , Ltd.
Gastroenterology & Urology · 210d
Cleared Sep 28, 2009
DBX DEMINERALIZED BONE MATRIX PUTTY
K091218 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 154d
Cleared Sep 28, 2009
SPINEWAND SURGICAL DEVICE
K091228 · GEI
Arthrocare Corp.
General & Plastic Surgery · 154d
Cleared Sep 28, 2009
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE...
K091246 · FSS
Trumpf Medizin Systeme GmbH + Co. KG
General & Plastic Surgery · 154d
Cleared Sep 28, 2009
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012,...
K091697 · GCJ
Transenterix, Inc.
General & Plastic Surgery · 110d
Cleared Sep 28, 2009
SHEATHESISO ULTRASOUND TRANSDUCER COVER
K091828 · ITX
Sheathing Technologies, Inc.
Radiology · 101d
Cleared Sep 28, 2009
DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST
K091919 · BZD
Sunrise Medical
Anesthesiology · 90d
Cleared Sep 28, 2009
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE...
K091920 · NHA
Astra Tech, Inc.
Dental · 90d
Cleared Sep 28, 2009
S8 ASPEN WITH H4I PLUS
K091947 · BZD
Resmed, Ltd.
Anesthesiology · 90d
Cleared Sep 28, 2009
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
K091981 · HQF
Lightmed Corp.
Ophthalmic · 89d
Cleared Sep 28, 2009
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
K091998 · OLO
Mako Surgical Corp.
Orthopedic · 88d
Cleared Sep 28, 2009
IROOT BP PLUS
K092715 · KIF
Innovative Bioceramix, Inc.
Dental · 25d
Cleared Sep 28, 2009
GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM
K092756 · ITX
Ge Vingmed Ultrasound AS
Radiology · 19d
Cleared Sep 25, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K082648 · LYZ
Tangshan Dar Plastic & Rubber...
General Hospital · 379d
Cleared Sep 25, 2009
SONOWAND INVITE
K083597 · HAW
Sonowand AS
Neurology · 294d
Cleared Sep 25, 2009
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25,...
K083868 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 270d
Cleared Sep 25, 2009
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
K090183 · KNQ
Cook Endoscopy
Gastroenterology & Urology · 242d
Cleared Sep 25, 2009
CONDUCTOR CORONARY GUIDEWIRE
K090193 · DQX
Concert Medical, LLC
Cardiovascular · 241d
Cleared Sep 25, 2009
ALPHA DUO LAP INSUFFLATOR
K090652 · HIF
Hippokratec GmbH
Obstetrics & Gynecology · 198d
Cleared Sep 25, 2009
BIOMET MODULAR FEMORAL REVISION SYSTEM
K090757 · KWA
Biomet, Inc.
Orthopedic · 186d
Cleared Sep 25, 2009
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
K091213 · FOS
Footprint Medical
General Hospital · 151d
Cleared Sep 25, 2009
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
K091214 · FOS
Footprint Medical
General Hospital · 151d
Cleared Sep 25, 2009
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT
K091280 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 147d
Cleared Sep 25, 2009
KNEEALIGN SYSTEM
K091411 · OLO
Orthalign, Inc.
Orthopedic · 135d