FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78913–78936 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 2001
JP CAST 50
K011330 · EJT
Jeneric/Pentron, Inc.
Dental · 51d
Cleared Jun 22, 2001
JP CAST 40
K011331 · EJT
Jeneric/Pentron, Inc.
Dental · 51d
Cleared Jun 22, 2001
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
K011435 · KPI
Hmt, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 22, 2001
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS...
K011584 · GZB
Medtronic Vascular
Neurology · 30d
Cleared Jun 22, 2001
MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
K011612 · FQH
Hydrocision, Inc.
General Hospital · 28d
Cleared Jun 22, 2001
THE AUTOTAC SYSTEM
K011675 · DZL
BioHorizons Implant Systems, Inc.
Dental · 23d
Cleared Jun 22, 2001
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG...
K011677 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 23d
Cleared Jun 22, 2001
BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
K011701 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 21d
Cleared Jun 22, 2001
STRYKER T4 HYTREL (R) TOGAS
K011755 · LYU
Stryker Corp.
General Hospital · 16d
Cleared Jun 22, 2001
DORNIER LITHOTRIPTER 140(DOLI 140)
K011773 · LNS
Dornier
Gastroenterology & Urology · 15d
Cleared Jun 22, 2001
PROCEDURE MASKS: PM4-301 AND PM4-304
K011789 · FXX
Primeline Medical Products, Inc.
General Hospital · 14d
Cleared Jun 21, 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA...
K002885 · JOZ
Dade Behring, Inc.
Hematology · 279d
Cleared Jun 21, 2001
EMBOGOLD MICROSPHERE
K010026 · HCG
Biosphere Medical, Inc.
Neurology · 169d
Cleared Jun 21, 2001
FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003,...
K010838 · DQY
Jomed AG
Cardiovascular · 93d
Cleared Jun 21, 2001
6F MACH 1, MODEL 34356-XXX
K010874 · DQY
Boston Scientific Corp
Cardiovascular · 90d
Cleared Jun 21, 2001
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
K011389 · JCM
Canterbury Health Laboratories
Hematology · 45d
Cleared Jun 21, 2001
MEDCOMP ASH SPLIT
K011576 · NFK
Medical Components, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 21, 2001
MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR...
K011593 · LZA
Ansell Healthcare Products, Inc.
General Hospital · 28d
Cleared Jun 21, 2001
INDUO BLOOD GLUCOSE METER
K011616 · NBW
Inverness Medical Innovations, Inc.
Chemistry · 27d
Cleared Jun 20, 2001
JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
K010406 · FOZ
Jms Co., Ltd.
General Hospital · 128d
Cleared Jun 20, 2001
JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
K010410 · FOZ
Jms Co., Ltd.
General Hospital · 128d
Cleared Jun 20, 2001
BIOSCANNER CREATININE TEST STRIPS
K010456 · JFY
Polymer Technology Systems, Inc.
Chemistry · 124d
Cleared Jun 20, 2001
NTI TENSION SUPPRESSION SYSTEM
K010876 · OCO
Nti-Tss, Inc.
Dental · 89d
Cleared Jun 20, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM
K010884 · HWC
Anchor Medical Technologies
Orthopedic · 89d