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
55825–55848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2008
PICASSO MASTER, ECT AND MASTER 3D
K081847 · JAK
E-Woo Technology
Radiology · 52d
Cleared Aug 21, 2008
ANYRAY PORTABLE X-RAY SYSTEM
K081899 · EHD
E-Woo Technology Co., Ltd.
Radiology · 49d
Cleared Aug 21, 2008
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES
K082099 · CGZ
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Aug 21, 2008
PCA-8000A, MARK 11, PET / CT SYSTEM
K082244 · KPS
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Aug 20, 2008
MEDILAS D FAMILY LASERS
K073427 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 258d
Cleared Aug 20, 2008
TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM
K080102 · ILY
Escada International, Inc.
Physical Medicine · 219d
Cleared Aug 20, 2008
JMEA CANNULATED BONE SCREW SYSTEM
K080259 · HWC
Jmea Corporation
Orthopedic · 202d
Cleared Aug 20, 2008
VIP PULMONARY FUNCTION SYSTEM
K080510 · BTY
Viasys Healthcare GmbH
Anesthesiology · 177d
Cleared Aug 20, 2008
POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)
K081657 · LYZ
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 69d
Cleared Aug 20, 2008
REVELATION HIP STEM, MODELS, 427-01, 427-02
K081679 · LPH
Encore Medical, L.P.
Orthopedic · 64d
Cleared Aug 20, 2008
GENTIAN CYSTATIN C IMMUNOASSAY
K081875 · NDY
Gentian AS
Chemistry · 49d
Cleared Aug 20, 2008
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
K081896 · MQK
Biogenics, Inc.
Obstetrics & Gynecology · 48d
Cleared Aug 19, 2008
TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
K080641 · NBW
Home Diagnostics, Inc.
Chemistry · 166d
Cleared Aug 19, 2008
AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ
K080872 · LDJ
Amedica Biotech, Inc.
Chemistry · 141d
Cleared Aug 19, 2008
AXIUM DETACHABLE COIL SYSTEM
K081465 · KRD
Micro Therapeutics, Inc.
Cardiovascular · 84d
Cleared Aug 19, 2008
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
K081549 · NTE
Abbott Laboratories
Cardiovascular · 77d
Cleared Aug 19, 2008
INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER
K082061 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 29d
Cleared Aug 19, 2008
CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
K082191 · NQH
Cardiomems, Inc.
Cardiovascular · 15d
Cleared Aug 19, 2008
HAIDA MODEL HD11 MANUAL WHEELCHAIR
K082274 · IOR
Jiangyin East China Medical...
Physical Medicine · 8d
Cleared Aug 19, 2008
HAIDA HD21
K082288 · ITI
Jiangyin East China Medical...
Physical Medicine · 8d
Cleared Aug 18, 2008
ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
K072708 · FGE
Abbott Vascular-Vascular Solutions
Gastroenterology & Urology · 328d
Cleared Aug 18, 2008
SURGIMESH XB
K072974 · FTL
Aspide Medical
General & Plastic Surgery · 301d
Cleared Aug 18, 2008
TRITON MEIDCAL TMED IV-SET
K073444 · FPA
Triton Medical, LLC
General Hospital · 255d
Cleared Aug 18, 2008
DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
K073579 · FTL
Feg Textiltechnik Forschungs-Und...
General & Plastic Surgery · 242d