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
75577–75600 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2002
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING...
K020587 · KRB
Pulsion Medical Systems AG
Cardiovascular · 90d
Cleared May 23, 2002
BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
K020620 · KWQ
Blackstone Medical, Inc.
Orthopedic · 87d
Cleared May 23, 2002
FINESUN EMS STIMULATOR
K020684 · IPF
Finesun Worldwide Intl. Co., Ltd.
Physical Medicine · 80d
Cleared May 23, 2002
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
K020914 · JBP
Helena Laboratories
Hematology · 63d
Cleared May 23, 2002
MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT...
K021286 · JAQ
Nucletron Corp.
Radiology · 30d
Cleared May 23, 2002
EBI DFS OPTIROM ELBOW FIXATOR
K021312 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared May 23, 2002
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
K021324 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 27d
Cleared May 22, 2002
AVEA
K013642 · CBK
Bird Products Corp.
Anesthesiology · 198d
Cleared May 22, 2002
ULTRAGARD IMPERVIOUS REINFORCED GOWN
K013846 · FYA
Precept Medical Products, Inc.
General Hospital · 183d
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