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

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176,076 results
80761–80784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2001
OFFSET TIBIAL TRAY
K010212 · MBV
Biomet, Inc.
Orthopedic · 22d
Cleared Feb 14, 2001
ELECSYS HCG+B CALCHECK
K010237 · JJX
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Feb 14, 2001
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP,...
K010246 · HRX
Kyphon, Inc.
Orthopedic · 19d
Cleared Feb 14, 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K010342 · MWI
Agilent Technologies, Inc.
Cardiovascular · 9d
Cleared Feb 14, 2001
BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308,...
K010343 · DZE
Buck Medical Research
Dental · 9d
Cleared Feb 13, 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K001585 · LPL
American Biocurve, Inc.
Ophthalmic · 267d
Cleared Feb 13, 2001
TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
K002583 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 179d
Cleared Feb 13, 2001
SALUTE
K003522 · GDW
Onux Medical, Inc.
General & Plastic Surgery · 90d
Cleared Feb 13, 2001
MOJAVE CATARACT EXTRACTION SYSTEM
K003638 · HQC
Allergan, Inc.
Ophthalmic · 81d
Cleared Feb 13, 2001
SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES...
K003833 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 64d
Cleared Feb 13, 2001
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
K003853 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 63d
Cleared Feb 13, 2001
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
K010004 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 42d
Cleared Feb 13, 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Feb 13, 2001
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169 · DQY
C.R. Bard, Inc.
Cardiovascular · 26d
Cleared Feb 13, 2001
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER...
K010340 · LNS
Karl Storz Lithotripsy-America, Inc.
Gastroenterology & Urology · 8d
Cleared Feb 12, 2001
LORENZ RESORBABLE DISTRACTOR SYSTEM
K002083 · JEY
Walter Lorenz Surgical, Inc.
Dental · 217d
Cleared Feb 12, 2001
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
K003510 · LLZ
Visualization Technology, Inc.
Radiology · 90d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200
K003514 · IYN
Shimadzu Medical Systems
Radiology · 90d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
K003515 · IYN
Shimadzu Medical Systems
Radiology · 90d
Cleared Feb 12, 2001
SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY...
K003526 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 88d
Cleared Feb 12, 2001
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
K003529 · LNS
Edap Technomed, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 12, 2001
SERENOCEM, MODEL BC 010
K003567 · NEA
Corinthian Medical , Ltd.
Ear, Nose, Throat · 84d
Cleared Feb 12, 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · FMF
Terumo Medical Corp.
General Hospital · 84d
Cleared Feb 12, 2001
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
K003668 · CGZ
Wallac OY
Chemistry · 76d