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
75073–75096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2002
LATEX SURGEONS GLOVE (POWDER FREE)
K014283 · KGO
Brightway Gloves Pvt. , Ltd.
General Hospital · 146d
Cleared May 22, 2002
MEDCOMP ASH SPLIT-CATH II
K020465 · MSD
Medcomp
Gastroenterology & Urology · 99d
Cleared May 22, 2002
APPLIED URETERAL CATHETER
K020577 · EYB
Applied Medical Resources Corp.
Gastroenterology & Urology · 90d
Cleared May 22, 2002
N2000 BASE STATION
K020584 · DXN
Neptec Design Group, Ltd.
Cardiovascular · 90d
Cleared May 22, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
K020600 · KWQ
Blackstone Medical, Inc.
Orthopedic · 89d
Cleared May 22, 2002
ORION NASAL CPAP SYSTEM
K020730 · BZD
Bird Products Corp.
Anesthesiology · 77d
Cleared May 22, 2002
IMAGINE H.E. PRESS DESIGN-CERAMIC
K020774 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 72d
Cleared May 22, 2002
HDM97
K020908 · FIZ
Ibp Instruments GmbH
Gastroenterology & Urology · 63d
Cleared May 22, 2002
HDM99
K020909 · FIZ
Ibp Instruments GmbH
Gastroenterology & Urology · 63d
Cleared May 22, 2002
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
K021013 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 54d
Cleared May 22, 2002
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0
K021082 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 49d
Cleared May 22, 2002
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
K021225 · DXN
Rossmax International , Ltd.
Cardiovascular · 34d
Cleared May 22, 2002
ECLIPSE, HELIOS OPTION
K021268 · MUJ
Varian Medical Systems, Inc.
Radiology · 30d
Cleared May 22, 2002
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
K021323 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 26d
Cleared May 22, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
K021435 · MWI
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared May 22, 2002
TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM
K021447 · DXN
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 16d
Cleared May 22, 2002
OCO DENTAL IMPLANT
K021460 · NHA
"O" Co., Inc.
Dental · 15d
Cleared May 22, 2002
MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
K021465 · LYY
Industrial Clothings, Ltd.
General Hospital · 15d
Cleared May 22, 2002
HISPEED DUAL
K021491 · JAK
Ge Medical Systems, Inc.
Radiology · 13d
Cleared May 22, 2002
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT...
K021591 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 7d
Cleared May 21, 2002
TST - SUPPRESSOR MODEL #1000
K013827 · KLW
Neurosim Limited
Ear, Nose, Throat · 183d
Cleared May 21, 2002
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
K013897 · MQB
Bio-Scan S.A
Radiology · 179d
Cleared May 21, 2002
KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT
K013982 · KRR
Kinamed, Inc.
Orthopedic · 169d
Cleared May 21, 2002
MEDAMICUS AXIA RSN
K020563 · DYB
Medamicus, Inc.
Cardiovascular · 90d