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
71473–71496 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2003
SCANLUBE
K031222 · MUI
Sonotech, Inc.
Radiology · 97d
Cleared Jul 23, 2003
XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE
K031256 · FDA
Olympus Opto-Electronics Co., Ltd.
Gastroenterology & Urology · 93d
Cleared Jul 23, 2003
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
K031390 · LGZ
Minimed, Inc.
General Hospital · 82d
Cleared Jul 23, 2003
RAPIDO CUT-AWAY CUTTER
K031459 · DQY
Guidant Corp.
Cardiovascular · 76d
Cleared Jul 23, 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512 · DIO
Dade Behring, Inc.
Toxicology · 70d
Cleared Jul 23, 2003
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
K031575 · JJY
Cliniqa Corporation
Immunology · 64d
Cleared Jul 23, 2003
CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001
K031920 · ITX
Trans Vascular Incorporated
Radiology · 30d
Cleared Jul 22, 2003
EKOS PERIPHERAL INFUSION SYSTEM
K030637 · QEY
Ekos Corp.
Cardiovascular · 144d
Cleared Jul 22, 2003
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
K031161 · DRF
Biosense Webster, Inc.
Cardiovascular · 99d
Cleared Jul 22, 2003
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K031355 · NKB
Ebi, L.P.
Orthopedic · 84d
Cleared Jul 22, 2003
EBI SPINELINK SPINAL FIXATION SYSTEM
K031424 · NKB
Ebi, L.P.
Orthopedic · 77d
Cleared Jul 22, 2003
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
K032103 · DSH
Philips Medical Systems
Cardiovascular · 14d
Cleared Jul 21, 2003
TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
K024377 · QJQ
Kalaco Scientific, Inc.
Neurology · 202d
Cleared Jul 21, 2003
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
K030033 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 199d
Cleared Jul 21, 2003
ORLON NONABSORABLE SURGICAL SUTURE USP
K030177 · GAR
Sri Orion Pharmaceuticals & Sutures
General & Plastic Surgery · 185d
Cleared Jul 21, 2003
SAPPHIRE DETACHABLE COIL SYSTEM
K030392 · HCG
Micro Therapeutics, Inc.
Neurology · 166d
Cleared Jul 21, 2003
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K030442 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 160d
Cleared Jul 21, 2003
ENDOS DC
K030634 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 144d
Cleared Jul 21, 2003
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K030926 · FZP
Advanced Surgical Products, Inc.
General & Plastic Surgery · 119d
Cleared Jul 21, 2003
GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)
K031085 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 108d
Cleared Jul 21, 2003
MODIFICATION TO STRYKER PAINPUMP
K031249 · FRN
Stryker Instruments
General Hospital · 94d
Cleared Jul 21, 2003
DUNLEE FORMAT COLLIMATOR FAMILY
K031597 · IZW
Philips Medical Systems North America...
Radiology · 61d
Cleared Jul 21, 2003
SLED CURING LIGHT SYSTEM
K031615 · EBZ
Dentsply International
Dental · 59d
Cleared Jul 21, 2003
CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION
K031638 · LLZ
Electromed Imaging, Inc.
Radiology · 55d