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

Filters: Cleared only ×
176,076 results
68809–68832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2004
WILOSN-COOK BILIARY DILATION BALLOON
K040800 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 25, 2004
QUANTA LITE GP210 ELISA
K040885 · NRI
Inova Diagnostics, Inc.
Immunology · 81d
Cleared Jun 25, 2004
EBI DISTAL RADIUS PLATING SYSTEM
K040908 · HRS
Ebi, L.P.
Orthopedic · 79d
Cleared Jun 25, 2004
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
K041009 · CIC
Hemagen Diagnostics, Inc.
Chemistry · 67d
Cleared Jun 25, 2004
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
K041017 · JOJ
Spsmedical Supply Corp.
General Hospital · 66d
Cleared Jun 25, 2004
IMALUX OCT PROBE GUIDE
K041077 · KKX
Imalux Corporation
General Hospital · 60d
Cleared Jun 25, 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · FRN
Baxter Healthcare Corp
General Hospital · 50d
Cleared Jun 25, 2004
JOEY CLAMP OPENING TOOL
K041332 · HFW
Maternus, Inc.
Obstetrics & Gynecology · 37d
Cleared Jun 25, 2004
GC FUSION
K041398 · ELW
GC America, Inc.
Dental · 30d
Cleared Jun 25, 2004
CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL
K041425 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Jun 25, 2004
OPUS MAGNUM ANCHOR WITH INSERTER
K041440 · MBI
Opus Medical, Inc.
Orthopedic · 24d
Cleared Jun 25, 2004
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
K041557 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 15d
Cleared Jun 25, 2004
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K041577 · LNH
Adac Laboratories
Radiology · 11d
Cleared Jun 24, 2004
BIO-EUROLIG INTERFERENCE SCREW
K031939 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 367d
Cleared Jun 24, 2004
WAFER SYSTEM
K033303 · HRS
Spine Wave, Inc.
Orthopedic · 254d
Cleared Jun 24, 2004
POWDER FREE LATEX EXAMINATION GLOVES
K033533 · LYY
Apl International Incorporated Limited
General Hospital · 227d
Cleared Jun 24, 2004
TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020,...
K034053 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 177d
Cleared Jun 24, 2004
INSPEKTOR PRO
K040063 · NBL
Inspektor Dental Care BV
Dental · 163d
Cleared Jun 24, 2004
TSY SHOULDER PLATE IMPLANT
K040850 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 85d
Cleared Jun 24, 2004
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
K041280 · KZE
Felton International, Inc.
General Hospital · 42d
Cleared Jun 24, 2004
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
K041370 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 31d
Cleared Jun 24, 2004
SMARTLITE PS PEN-STYLE LED CURING LIGHT
K041372 · EBZ
Dentsply International
Dental · 31d
Cleared Jun 24, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041452 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Jun 24, 2004
MONOCHROME LCD MONITOR, MODEL RADIFORCE G22
K041597 · LLZ
Eizo Nanao Corporation
Radiology · 30d