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
35257–35280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 2015
VENUS Spinal Fixation System
K143363 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 149d
Cleared Apr 22, 2015
Relieva SpinPlus Balloon Sinuplasty System
K143541 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 128d
Cleared Apr 22, 2015
Reverse Medical Micro Vascular Plug System
K150108 · KRD
Reverse Medical Corporation
Cardiovascular · 92d
Cleared Apr 22, 2015
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels,...
K150235 · DRQ
Boston Scientific Corporation
Cardiovascular · 79d
Cleared Apr 21, 2015
Tranberg CLS Thermal Therapy System
K142216 · GEX
Clinical Laserthermia Systems, AB
General & Plastic Surgery · 252d
Cleared Apr 21, 2015
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS...
K142994 · CJM
Immunodiagnostic Systems , Ltd.
Chemistry · 187d
Cleared Apr 21, 2015
Portrait GBS Assay
K143312 · NJR
Great Basin Corporation
Microbiology · 154d
Cleared Apr 21, 2015
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K143341 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 151d
Cleared Apr 21, 2015
Melodi Prime Breast Pump
K143574 · HGX
Genadyne Biotechnologies, Inc.
Obstetrics & Gynecology · 125d
Cleared Apr 21, 2015
Basic, Dominant Flex, KV-6
K150134 · QPB
Medela AG
General & Plastic Surgery · 90d
Cleared Apr 21, 2015
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor...
K150499 · HGX
Medela AG
Obstetrics & Gynecology · 54d
Cleared Apr 20, 2015
I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
K132663 · NBW
Alliance International Co., Ltd.
Chemistry · 602d
Cleared Apr 20, 2015
RHINOGUARD
K141747 · BTR
Davis Medical
Anesthesiology · 294d
Cleared Apr 20, 2015
MALE CIRCUMCISION KITS:RAPIDECLAMP
K142163 · HFX
Medicfit Technology Sdn Bhd
Obstetrics & Gynecology · 257d
Cleared Apr 20, 2015
TensCare KegelFit
K142506 · KPI
Tenscare, Ltd.
Gastroenterology & Urology · 224d
Cleared Apr 20, 2015
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health...
K143016 · OMP
Cardinalhealth
General & Plastic Surgery · 182d
Cleared Apr 20, 2015
G-Premio BOND
K143140 · KLE
GC America, Inc.
Dental · 168d
Cleared Apr 20, 2015
Natus Quantum
K143440 · GWQ
Natus Medical Incorporated
Neurology · 139d
Cleared Apr 20, 2015
IPM Wound Gel Bio, IPM Derm Gel Bio
K143527 · FRO
Glycobiosciences, Inc.
General & Plastic Surgery · 129d
Cleared Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
K143739 · LZO
Smith & Nephew, Inc.
Orthopedic · 111d
Cleared Apr 20, 2015
Air Compressible Limb Therapy System
K150033 · IRP
Daesung Maref Co., Ltd.
Physical Medicine · 101d
Cleared Apr 20, 2015
PROFEMUR Preserve Size 1-3 Hip Stems
K150133 · LZO
Microport Orthopedics, Inc.
Orthopedic · 89d
Cleared CT Apr 20, 2015
DeScribe Transparent PFD Patch
K150212 · PKO
On Light Sciences, Inc.
General & Plastic Surgery · 80d
Cleared Apr 20, 2015
Tosama 100% Cotton Menstrual Tampon
K150897 · HEB
Tosama, D.O.O.
Obstetrics & Gynecology · 18d