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
37561–37584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2014
PHILIPS PROGRADE
K141736 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 28d
Cleared Jul 25, 2014
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
K141838 · GEX
Regulatory Technology Services, LLC
General & Plastic Surgery · 17d
Cleared Jul 24, 2014
NOVAPROBE LED LIGHT SOURCE
K131226 · FCW
Novaprobe Incorporated
Gastroenterology & Urology · 450d
Cleared Jul 24, 2014
THERMOPULSE
K131926 · IMJ
Ibramed Equipamentos Medicos
Physical Medicine · 393d
Cleared Jul 24, 2014
NOBELPROCERA OVERDENTURE BAR
K132749 · NHA
Nobel Biocare USA, LLC
Dental · 324d
Cleared Jul 24, 2014
PLIF LITE AND TLIF LITE
K132907 · MAX
Sintea Plustek
Orthopedic · 310d
Cleared Jul 24, 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 280d
Cleared Jul 24, 2014
PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED...
K133336 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 268d
Cleared Jul 24, 2014
HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
K133670 · LNH
Neocoil, LLC
Radiology · 237d
Cleared Jul 24, 2014
MICR02 OSA DEVICE
K133683 · LRK
Microdental, Inc.
Dental · 234d
Cleared Jul 24, 2014
C-JAWS CERVICAL COMPRESSIVE STAPLE
K133906 · PHQ
Medicrea International
Orthopedic · 213d
Cleared Jul 24, 2014
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
K140096 · DRX
Hmicro, Inc.
Cardiovascular · 191d
Cleared Jul 24, 2014
FLEXI-LUME LED SYSTEM
K140281 · EBZ
Epic Medical Concepts & Innovations
Dental · 170d
Cleared Jul 24, 2014
GIS ENDOSCOPIC OPTICAL LENS
K140295 · FDS
Gi Scientific, LLC
Gastroenterology & Urology · 168d
Cleared Jul 24, 2014
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
K140498 · MLR
STERIS Corporation
General Hospital · 147d
Cleared Jul 24, 2014
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
K140523 · FED
Coloplast A/S
Gastroenterology & Urology · 142d
Cleared Jul 24, 2014
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE...
K140890 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 107d
Cleared Jul 24, 2014
COLONGLIDE LUBRICANT
K141028 · KMJ
Pediatric Pharmaceuticals, Inc.
General Hospital · 93d
Cleared Jul 24, 2014
AMPLIVUE GAS ASSAY
K141173 · PGX
Quidel Corporation
Microbiology · 79d
Cleared Jul 24, 2014
LINOS MOH HAND PLATING SYSTEM
K141489 · HRS
KLS-Martin L.P.
Orthopedic · 49d
Cleared Jul 24, 2014
PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE...
K141711 · MBI
Pontis Orthopaeeics, LLC
Orthopedic · 29d
Cleared Jul 24, 2014
HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
K141750 · LCP
Infopia Co, Ltd.
Chemistry · 24d
Cleared Jul 23, 2014
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
K132820 · JDW
Vilex, Inc.
Orthopedic · 317d
Cleared Jul 23, 2014
SIS HERNIA GRAFT
K133306 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 268d