FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
17305–17328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 2021
MAC 7 - Resting ECG Analysis System
K203786 · DPS
Ge Medical Systems Information...
Cardiovascular · 123d
Cleared Apr 30, 2021
HYPER AiR
K210001 · KPS
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Apr 30, 2021
ProLift Lateral HELO Fixated
K210061 · MAX
Life Spine, Inc.
Orthopedic · 109d
Cleared Apr 30, 2021
OsteoCentric Integrated Hip Fastener System
K210247 · JDO
Osteocentric Technologies D.B.A....
Orthopedic · 91d
Cleared Apr 30, 2021
JACE Medical Thoracic Plating System
K210290 · HRS
Jace Medical, LLC
Orthopedic · 87d
Cleared Apr 30, 2021
CD Horizon™ Spinal System
K210637 · NKB
Medtronic
Orthopedic · 58d
Cleared Apr 30, 2021
SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT...
K210647 · DQY
Vascular Solutions, LLC
Cardiovascular · 58d
Cleared Apr 30, 2021
AcuityDRe
K210919 · MQB
Radmedix, LLC
Radiology · 32d
Cleared Apr 30, 2021
CereLink ICP Monitor
K210993 · GWM
Integra Lifesciences Production...
Neurology · 28d
Cleared Apr 30, 2021
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16,...
K211013 · QEW
Inari Medical, Inc.
Cardiovascular · 25d
Cleared Apr 29, 2021
Expandable Titanium PLIF/TLIF System
K201024 · MAX
Spectrum Spine, LLC
Orthopedic · 374d
Cleared Apr 29, 2021
M1 Surgical Face Mask
K202457 · FXX
CHISON Medical Technologies Co., Ltd.
General Hospital · 245d
Cleared Apr 29, 2021
KardiFlex PTCA Balloon Dilatation Catheter
K202619 · LOX
Medcaptain Life Science Co., Ltd.
Cardiovascular · 231d
Cleared Apr 29, 2021
Rescue Pulmonary Grasping Forceps
K202987 · EOQ
Anrei Medical (Hangzhou) Co., Ltd.
Anesthesiology · 211d
Cleared Apr 29, 2021
Infrared Thermometer
K203454 · FLL
Shandong Zhushi Pharmaceutical Group...
General Hospital · 157d
Cleared Apr 29, 2021
3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
K210605 · DWJ
3M Company
Cardiovascular · 59d
Cleared Apr 29, 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs...
K210944 · LZA
Harbour Health, LLC
General Hospital · 30d
Cleared Apr 29, 2021
Pure Vu System
K210981 · FDF
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 28d
Cleared Apr 28, 2021
MPACT Extension
K200391 · LPH
Medacta International S.A.
Orthopedic · 435d
Cleared Apr 28, 2021
CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer,...
K202757 · DXN
Contec Medical Systems Co.,Ltd
Cardiovascular · 219d
Cleared Apr 28, 2021
Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
K203277 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 173d
Cleared Apr 28, 2021
Disposable Nitrile Examination Gloves
K203436 · LZA
Shandong Zhushi Pharmaceutical Group...
General Hospital · 156d
Cleared Apr 28, 2021
TCL3 Motion Tracking System
K203451 · LNH
Tracinnovations Aps
Radiology · 156d
Cleared Apr 28, 2021
BI-MENTUM™ ALTRX® Dual Mobility Liner
K203532 · LZO
Depuy Ireland UC
Orthopedic · 147d