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
71209–71232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2003
CD HORIZON SPINAL SYSTEM
K031655 · MNI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jun 27, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031888 · MNI
Medtronic Sofamor Danek
Orthopedic · 9d
Cleared Jun 26, 2003
SMART BAG MO
K021328 · BTM
O-Two Systems International, Inc.
Anesthesiology · 426d
Cleared Jun 26, 2003
OSMONICS SOLUTION DELIVERY SYSTEM
K023011 · FIN
Osmonics Medical Systems
Gastroenterology & Urology · 290d
Cleared Jun 26, 2003
METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON...
K024000 · DQO
Angiometrx, Inc.
Cardiovascular · 204d
Cleared Jun 26, 2003
PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM
K024181 · IPF
Prizm Medical, Inc.
Physical Medicine · 189d
Cleared Jun 26, 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · MNH
Blackstone Medical, Inc.
Orthopedic · 122d
Cleared Jun 26, 2003
MINILOK QUICKANCHOR PLUS
K030995 · HWC
Mitek Worldwide
Orthopedic · 87d
Cleared Jun 26, 2003
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
K031027 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 86d
Cleared Jun 26, 2003
TS3 TUBING SET
K031151 · DWF
Global Blood Resources, LLC
Cardiovascular · 77d
Cleared Jun 26, 2003
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE...
K031414 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 52d
Cleared Jun 26, 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND...
K031591 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 36d
Cleared Jun 26, 2003
WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
K031622 · MQE
Portex , Ltd.
Obstetrics & Gynecology · 34d
Cleared Jun 26, 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · DQY
Cook, Inc.
Cardiovascular · 17d
Cleared Jun 25, 2003
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM
K014013 · FLF
H & W Technology, LLC
General Hospital · 567d
Cleared Jun 25, 2003
DETECTAR, MODEL N123-MI
K023367 · EJB
Neks Technologies
Dental · 260d
Cleared Jun 25, 2003
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
K023817 · MNW
Clio Designs, Inc.
Gastroenterology & Urology · 222d
Cleared Jun 25, 2003
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
K030035 · JFY
Diametrics Medical, Inc.
Chemistry · 173d
Cleared Jun 25, 2003
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
K030708 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 111d
Cleared Jun 25, 2003
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
K030990 · CAH
Datex-Ohmeda
General Hospital · 89d
Cleared Jun 25, 2003
MIRACLE 98
K031010 · EJT
Sb Lucius, Inc.
Dental · 86d
Cleared Jun 25, 2003
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K031159 · JIT
Diamond Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 25, 2003
QUANTA PLEX ENA PROFILE 6
K031450 · LLL
Inova Diagnostics, Inc.
Immunology · 49d