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
53089–53112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2009
VIPER 2 SYSTEM
K090648 · NKB
Depuy Spine, Inc.
Orthopedic · 91d
Cleared Jun 10, 2009
HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
K090680 · NZW
Becton, Dickinson & CO
General Hospital · 86d
Cleared Jun 10, 2009
MI FLOW (GCUC-450)
K090747 · EBF
GC America, Inc.
Dental · 82d
Cleared Jun 10, 2009
CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS...
K090821 · GDW
Frankenman International Limited
General & Plastic Surgery · 76d
Cleared Jun 10, 2009
THEKEN CORAL SPINAL SYSTEM
K091266 · NKB
Theken Spine, LLC
Orthopedic · 41d
Cleared Jun 10, 2009
COR12+
K091505 · DSH
Viasys Healthcare GmbH
Cardiovascular · 20d
Cleared Jun 10, 2009
MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1
K091589 · FLL
Microlife Intellectual Property GmbH
General Hospital · 8d
Cleared Jun 09, 2009
PRECISION ENDOSCOPIC INFRARED COAGULATOR
K083275 · KNS
Max Endoscopy, Inc.
Gastroenterology & Urology · 215d
Cleared Jun 09, 2009
MAXMORESPINE SPINAL SYSTEM
K090132 · HRX
Hoogland Spine Products, GmbH
Orthopedic · 139d
Cleared Jun 09, 2009
EPIPHANY INJECTION SYSTEM
K090161 · MSS
Staar Surgical Co.
Ophthalmic · 138d
Cleared Jun 09, 2009
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330,...
K091340 · FPD
Boston Scientific Corp
Gastroenterology & Urology · 34d
Cleared Jun 08, 2009
OBI
K083669 · DZE
Euroteknika
Dental · 179d
Cleared Jun 08, 2009
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
K083716 · LCX
Church & Dwight Co., Inc.
Chemistry · 175d
Cleared Jun 08, 2009
NUVASIVE NEURO VISION SYSTEM
K090298 · GWF
Nuvasive, Inc.
Neurology · 122d
Cleared Jun 08, 2009
MODIFICATION TO NORDICICE SOFTWARE
K090546 · LLZ
Nordicimaginglab AS
Radiology · 98d
Cleared Jun 08, 2009
CAPIOX BUBBLE TRAP WITH X-COATING
K090698 · KRL
Terumo Cardiovascular Systems
Cardiovascular · 83d
Cleared Jun 08, 2009
SMITH & NEPHEW RAIL SYSTEM
K090926 · KTT
Smith & Nephew, Inc.
Orthopedic · 67d
Cleared Jun 08, 2009
SERAQUEST EBV EA-D IGG TEST
K091260 · LSE
Quest Intl., Inc.
Microbiology · 40d
Cleared CT Jun 05, 2009
CORTOSS BONE AUGMENTATION MATERIAL
K080108 · NDN
Orthovita, Inc.
Orthopedic · 507d
Cleared Jun 05, 2009
EXALIS, SOFTWARE VERSION 1.15
K083158 · KDI
Gambro, Inc.
Gastroenterology & Urology · 224d
Cleared Jun 05, 2009
MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN
K083195 · EBG
Lang Dental Mfg. Co., Inc.
Dental · 219d
Cleared Jun 05, 2009
PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
K083415 · GEI
Peak Surgical, Inc.
General & Plastic Surgery · 199d
Cleared Jun 05, 2009
A6 LUER ACCESS DEVICE
K083723 · FPA
B.Braun Medical, Inc.
General Hospital · 172d
Cleared Jun 05, 2009
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
K083862 · DRG
Medapps, Inc.
Cardiovascular · 158d