FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
78409–78432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 20, 2001
PTW DOSIMETRY DIODE, T60008
K010916 · IYE
Ptw-New York Corp.
Radiology · 85d
Cleared Jun 20, 2001
SEALAPEX 4
K010940 · KIF
Sybron Dental Specialties, Inc.
Dental · 83d
Cleared Jun 20, 2001
DRIDAU OPIATE ASSAY
K011150 · DJG
Microgenics Corp.
Toxicology · 65d
Cleared Jun 20, 2001
THIN FILM DRESSING FOR ULTRASOUND EXAM
K011284 · ITX
Martin E. Wendelken
General & Plastic Surgery · 54d
Cleared Jun 20, 2001
ZIEHM VISION
K011292 · OWB
Ziehm International, Inc.
Radiology · 51d
Cleared Jun 20, 2001
NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET
K011297 · FOZ
Nipro Medical Corp.
General Hospital · 51d
Cleared Jun 20, 2001
Q-RAD RADIOGRAPHIC SYSTEM
K011486 · KPR
Quantum Medical Imaging, LLC
Radiology · 36d
Cleared Jun 20, 2001
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
K011656 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Jun 20, 2001
ACCU-CHEK ACTIVE SYSTEM
K011738 · NBW
Roche Diagnostics Corp.
Chemistry · 15d