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

Filters: Cleared only ×
175,820 results
36313–36336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2014
DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT
K131643 · NUC
Reckitt Benckiser, LLC
Obstetrics & Gynecology · 560d
Cleared Dec 17, 2014
GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
K140284 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 316d
Cleared Dec 17, 2014
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE...
K140536 · DQX
Lake Region Medical
Cardiovascular · 288d
Cleared Dec 17, 2014
CERAGEM AUTOMATIC THERMAL MASSAGER
K140592 · JFB
Ceragem International, Inc.
Physical Medicine · 285d
Cleared Dec 17, 2014
NANOSTIM INTRODUCER KIT
K140793 · DYB
St. Jude Medical, Inc.
Cardiovascular · 261d
Cleared Dec 17, 2014
LUMINESSE PORCELAIN SYSTEM
K140848 · EIH
Talladium, Inc.
Dental · 258d
Cleared Dec 17, 2014
STERIZONE STERILIZER
K141163 · PJJ
Tso3, Inc.
General Hospital · 226d
Cleared Dec 17, 2014
VIDEO BRONCHOSCOPE SYSTEM
K141366 · EOQ
Scholly Fiberoptic GmbH
Ear, Nose, Throat · 208d
Cleared Dec 17, 2014
STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
K141580 · FRC
Tso3, Inc.
General Hospital · 187d
Cleared Dec 17, 2014
GEN_3
K141691 · IOR
Free Wheelchair Mission
Physical Medicine · 176d
Cleared Dec 17, 2014
STERIZONE CHEMICAL INDICATOR
K141698 · JOJ
Tso3, Inc.
General Hospital · 176d
Cleared Dec 17, 2014
PRELUDE PLASTIC JACKETED GUIDE WIRE
K142051 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 142d
Cleared Dec 17, 2014
ACCU-CHEK AVIVA EXPERT SYSTEM
K142089 · LFR
Roche Diagnostics Corporation
Chemistry · 138d
Cleared Dec 17, 2014
MANIPULATOR
K142164 · LKF
Gynetech Pty. , Ltd.
Obstetrics & Gynecology · 133d
Cleared Dec 17, 2014
The OnControl Bone Marrow Biopsy System by Vidacare
K142377 · KNW
Vidacare, LLC
Gastroenterology & Urology · 113d
Cleared Dec 17, 2014
GM60A-32S, GM60A-40S
K142492 · IZL
Samsung Electronics Co., Ltd.
Radiology · 104d
Cleared Dec 17, 2014
Powder Free Vinyl Patient Examination Gloves
K142571 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 96d
Cleared Dec 17, 2014
Radlink GPS
K142718 · MQB
Radlink, Inc.
Radiology · 85d
Cleared Dec 17, 2014
cobas MRSA/SA Test
K142721 · NQX
Roche Molecular Systems, Inc.
Microbiology · 85d
Cleared Dec 17, 2014
HEPATIQ
K142891 · LLZ
Hepatiq, LLC
Radiology · 75d
Cleared Dec 17, 2014
RTHawk, HeartVista Workstation with RTHawk
K142997 · LNH
Heartvista, Inc.
Radiology · 68d
Cleared Dec 17, 2014
InFill Graft Delivery System
K143488 · FMF
Pinnacle Spine Group, LLC
General Hospital · 9d
Cleared Dec 16, 2014
ImmersiveTouch3 and MicrovisTouch
K140860 · LLZ
Immersivetouch
Radiology · 257d
Cleared Dec 16, 2014
FORT DEFIANCE AUTOMATED STEAM STERILIZER
K141009 · FLE
Fort Defiance Industries, Inc.
General Hospital · 242d