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
50281–50304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2010
AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
K100623 · NKB
Aesculap Implant Systems
Orthopedic · 97d
Cleared Jun 09, 2010
SUCTION IRRIGATION ELECTRODES AND ADAPTERS
K100711 · GEI
Encision, Inc.
General & Plastic Surgery · 89d
Cleared Jun 09, 2010
GRAFT DELIVERY SYSTEM MODEL SA-6115
K100754 · FMF
Micromedics, Inc.
General Hospital · 84d
Cleared Jun 09, 2010
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
K100772 · BZD
Resmed, Ltd.
Anesthesiology · 83d
Cleared Jun 08, 2010
PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE
K092967 · OIW
Pathwork Diagnostics
Pathology · 256d
Cleared Jun 08, 2010
LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE...
K093193 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 238d
Cleared Jun 08, 2010
GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA...
K093729 · QSY
Hemcon Medical Technologies Europe, Ltd.
General & Plastic Surgery · 187d
Cleared Jun 08, 2010
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30
K100217 · MHX
Mediana Co., Ltd.
Cardiovascular · 134d
Cleared Jun 08, 2010
THL1 LASER
K100509 · NHN
Erchonia Corporation
Physical Medicine · 106d
Cleared Jun 08, 2010
A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200
K101002 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 57d
Cleared Jun 08, 2010
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER,...
K101008 · ITX
Shantou Institute of Ultrasonic...
Radiology · 57d
Cleared Jun 08, 2010
VITAL SIGNS MONITOR-VSM 6000 SERIES
K101445 · MWI
Welch Allyn, Inc.
Cardiovascular · 15d
Cleared Jun 07, 2010
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
K091845 · MID
Phadia US, Inc.
Immunology · 350d
Cleared Jun 07, 2010
PANPAC HSG CATHETER SET
K092983 · LKF
Panpac Medical Corporation
Obstetrics & Gynecology · 252d
Cleared Jun 07, 2010
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
K100807 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 07, 2010
FETAL MONITOR MODEL: BT-200T
K100885 · HGM
Bistos Co., Ltd.
Radiology · 69d
Cleared Jun 07, 2010
MODIFICATION TO SCINTRON IV
K101013 · KPS
Miegmbh
Radiology · 56d
Cleared Jun 04, 2010
HANAROSTENT ESOPHAGUS (CCC)
K093537 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 200d
Cleared Jun 04, 2010
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
K093853 · DQA
Nonin Medical, Inc.
Anesthesiology · 170d
Cleared Jun 04, 2010
SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009
K093975 · NHA
Pan Global Implant
Dental · 162d
Cleared Jun 04, 2010
SLEEPRIGHT
K100545 · OBR
Power Products, Inc.-Splintek
Dental · 98d
Cleared Jun 04, 2010
MIS SYSTEM
K100605 · MNH
Spine Wave, Inc.
Orthopedic · 93d
Cleared Jun 04, 2010
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K100708 · KWQ
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Jun 04, 2010
ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
K101277 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 29d