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
93505–93528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1997
HEARTPORT THORACIC TROCAR
K964302 · DRC
Heartport, Inc.
Cardiovascular · 192d
Cleared May 09, 1997
AD-TECH'S DEPTH ELECTRODE
K964644 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 190d
Cleared May 09, 1997
BLEDSOE COLD CONTROL
K964710 · ILO
Med Technology, Inc.
Physical Medicine · 165d
Cleared May 09, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
K964781 · DDS
Beckman Instruments, Inc.
Immunology · 163d
Cleared May 09, 1997
WINMAX SOFTWARE SYSTEMS
K965103 · JJF
Diagnostic Products Corp.
Chemistry · 140d
Cleared May 09, 1997
VALUETRODE
K970426 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 94d
Cleared May 09, 1997
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
K970441 · FPX
Medi-Flex Hospital Products, Inc.
General & Plastic Surgery · 93d
Cleared May 09, 1997
HANNIBAL GUIDEWIRE
K970494 · DQX
Schneider (Europe) GmbH
Cardiovascular · 88d
Cleared May 09, 1997
HEARTPORT MAZE SYSTEM: CRYOPROBE SET
K970496 · OCL
Heartport, Inc.
Cardiovascular · 88d
Cleared May 09, 1997
SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
K970516 · BZD
Resmed, Ltd.
Anesthesiology · 87d
Cleared May 09, 1997
AD-TECH SUBDURAL ELECTRODE
K970587 · GYC
Ad-Tech Medical Instrument Corp
Neurology · 80d
Cleared May 09, 1997
STAT PROFILE ULTRA M ANALYZER
K970710 · CHL
Nova Biomedical Corp.
Chemistry · 72d
Cleared May 09, 1997
OPTI-PLAST XL 5.5 F PTA CATHETER
K970725 · LIT
Vas-Cath, Inc.
Cardiovascular · 70d
Cleared May 09, 1997
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
K970746 · LPL
Ciba Vision Corporation
Ophthalmic · 70d
Cleared May 09, 1997
TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM
K970748 · KTT
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 67d
Cleared May 09, 1997
FOTONA SKINSCAN
K970757 · GEX
Medical Laser Solutions
General & Plastic Surgery · 67d
Cleared May 09, 1997
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K970779 · LZN
Osteonics Corp.
Orthopedic · 66d
Cleared May 09, 1997
T-RX RETRIEVAL FORCEPS
K970982 · OCZ
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 52d
Cleared May 09, 1997
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
K971048 · FTM
Bio-Vascular, Inc.
General & Plastic Surgery · 49d
Cleared May 09, 1997
UNIKA
K971327 · HQY
Eyewear Partners Co.
Ophthalmic · 29d
Cleared May 09, 1997
ECLIPSE 400 MANUALLY OPERATED WHEELCAIR
K971389 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 25d
Cleared May 08, 1997
STERITEC INTEGRAPH MODEL CI-101
K960441 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 462d
Cleared May 08, 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 210d
Cleared May 08, 1997
ACROMED PEDICLE SCREW
K965102 · MNH
Acromed Corp.
Orthopedic · 139d