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
91225–91248 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1998
ZIPPY
K972851 · ITI
Pillar Technology, Inc.
Physical Medicine · 160d
Cleared Jan 08, 1998
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K973868 · KWP
Osteotech, Inc.
Orthopedic · 90d
Cleared Jan 08, 1998
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
K973872 · OKS
Atrion Medical Products, Inc.
Ophthalmic · 90d
Cleared Jan 08, 1998
MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES
K973887 · DQA
Masimo Corp.
Anesthesiology · 86d
Cleared Jan 08, 1998
PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D
K973983 · LLZ
Philips Medical Systems, Inc.
Radiology · 80d
Cleared Jan 08, 1998
AUTOMATED DISPOSABLE KERATOME (ADK)
K974004 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 79d
Cleared Jan 08, 1998
AMBULATORY X-12 TELEMETRY MODULE
K974149 · DRG
Mortara Instrument, Inc.
Cardiovascular · 65d
Cleared Jan 08, 1998
VISTACAM OMNI AND VIASTCAM OMNI (IC)
K974204 · EIA
Air Techniques, Inc.
Dental · 59d
Cleared Jan 08, 1998
KSEA PLASTIC TROCARS
K974366 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 49d
Cleared Jan 08, 1998
CHEMO-SPIKE II RECONSTITUTION DEVICE
K974431 · LHI
Medi-Dose, Inc.
General Hospital · 45d
Cleared Jan 08, 1998
MANAN AUTOMATIC CUTTING NEEDLE
K974446 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 44d
Cleared Jan 08, 1998
MANAN ACCURA NEEDLE
K974741 · GAA
Medical Device Technologies, Inc.
General & Plastic Surgery · 20d
Cleared Jan 08, 1998
MANAN TECHNA-CUT ASPIRATION NEEDLE
K974766 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 08, 1998
TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R)...
K974827 · JJY
Biosite Incorporated
Chemistry · 15d
Cleared Jan 07, 1998
OVULON MONITOR
K973860 · NGE
Conception Technology, Inc.
Toxicology · 90d
Cleared Jan 07, 1998
TRACE REAGENT LINE FOR THE COBAS MIRA
K973869 · CKA
Trace America, Inc.
Chemistry · 105d
Cleared Jan 07, 1998
ELECTRODES/PROBES/DEVICES
K974637 · FAS
Ximed/Prosure/Injectx
Gastroenterology & Urology · 26d
Cleared Jan 06, 1998
SHENG HO
K964819 · LYY
Shang HO Industrial Corp. , Ltd.
General Hospital · 400d
Cleared Jan 06, 1998
SANKO INTRAORAL DENTAL X-RAY
K972921 · EHD
Sanko X-Ray Manufacturing Co., Ltd.
Radiology · 151d
Cleared Jan 06, 1998
PATIENT EXAMINATION POWDER-FREE GLOVES
K973020 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 146d
Cleared Jan 06, 1998
PRE-POWDERED PATIENT EXAMINATION GLOVE
K973831 · LYY
Safe Glove , Ltd.
General Hospital · 91d
Cleared Jan 06, 1998
PHILIPS EASYVISION WORKSTATION
K973835 · LLZ
Philips Medical Systems, Inc.
Radiology · 90d
Cleared Jan 06, 1998
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL
K973837 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 06, 1998
BIOABSORBABLE BANKART TACK
K973849 · MAI
Hogan & Hartson
Orthopedic · 90d