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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
126001–126024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1990
BURRON AMBULATORY DRUG DELIVERY SYSTEM
K896422 · FRN
Burron Medical, Inc.
General Hospital · 182d
Cleared May 09, 1990
DUALYSE-CATH - CODES #1132.212, 1132.112
K896568 · LFJ
Vygon Corp.
Gastroenterology & Urology · 170d
Cleared May 09, 1990
MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT
K900193 · OXO
Imt America, Inc.
Radiology · 113d
Cleared May 09, 1990
MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.
K900551 · DRS
Matrix Medica, Inc.
Cardiovascular · 92d
Cleared May 09, 1990
MODULAR HIP SYSTEM
K900628 · LZO
Richards Medical Co., Inc.
Orthopedic · 90d
Cleared May 09, 1990
UNIVERSAL DELIVERY SYSTEM CATHETER
K900657 · DQY
Microvena Corp.
Cardiovascular · 89d
Cleared May 09, 1990
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
K900815 · DTW
3M Company
Cardiovascular · 77d
Cleared May 09, 1990
MODIFIED PERM-CATH
K900835 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 76d
Cleared May 09, 1990
LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING
K900945 · KKX
Palex Medical, Inc.
General Hospital · 70d
Cleared May 09, 1990
MODIFIED ALPHA MC-9R C-ARM
K900967 · OXO
Instrumentarium Imaging, Inc.
Radiology · 68d
Cleared May 09, 1990
NDM SWITCHPEN HOLSTER
K901145 · GEI
Ndm Corp.
General & Plastic Surgery · 58d
Cleared May 09, 1990
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
K901332 · DTC
Biotronik, GmbH & Co.
Cardiovascular · 48d
Cleared May 09, 1990
BARD BIOPOTENTIAL AMPLIFIER II
K901358 · DRQ
C.R. Bard, Inc.
Cardiovascular · 47d
Cleared May 09, 1990
GABRIEL MEDICAL CLS THERMAL RECORDER
K901385 · DSF
Gabriel Medical, Inc.
Cardiovascular · 44d
Cleared May 09, 1990
ANEROID SPHYGMOMANOMETER, DOCTOR TYPE
K901506 · DXQ
Yamasu Co. , Ltd.
Cardiovascular · 40d
Cleared May 09, 1990
READS(R) ANTI-ENA (SM/RNP) TEST KIT
K901924 · LLL
Biosearch Medical Products, Inc.
Immunology · 9d
Cleared May 09, 1990
SURGICAL RETENTION BAR
K902001 · KGS
Acufex Microsurgical, Inc.
General & Plastic Surgery · 7d
Cleared May 07, 1990
VITAJET(INSULIN JET INJECTION DEVICE)
K893215 · KZE
Vitajet Industriae Comercioltda.
General Hospital · 375d
Cleared May 07, 1990
HPI ORTHO SURGEONS' GLOVE
K894828 · KGO
Tillotson Rubber Co., Inc.
General Hospital · 280d
Cleared May 07, 1990
THERMO-5000
K895358 · LHQ
Medtronix Ltd., Inc.
Radiology · 252d
Cleared May 07, 1990
FERMIT TEMPORARY MATERIAL
K896530 · EBF
Ivoclar North America, Inc.
Dental · 174d
Cleared May 07, 1990
PERLINK CASSETTE, KIRAN CASSETTE
K896708 · IXA
Perlink USA, Inc.
Radiology · 160d
Cleared May 07, 1990
ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K896755 · IYO
Ge Medical Systems Information...
Radiology · 157d
Cleared May 07, 1990
COATED NOVAFIL, POLYBUTESTER, MESH
K896946 · FTM
American Cyanamid Co.
General & Plastic Surgery · 145d