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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68521–68544 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2004
PANORET, MODEL PNM 60
K040325 · HKI
Medibell Medical Vision Technologies...
Ophthalmic · 27d
Cleared Mar 08, 2004
MODIFICATION TO E.P.T. PREGNANCY TEST
K040329 · LCX
Unipath , Ltd.
Chemistry · 26d
Cleared Mar 08, 2004
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341 · LCX
Unipath , Ltd.
Chemistry · 25d
Cleared Mar 08, 2004
VITALAB URIC ACID REAGENT
K040467 · KNK
Clinical Data, Inc.
Chemistry · 13d
Cleared Mar 08, 2004
VITALAB MAGNESIUM REAGENT
K040508 · JGJ
Clinical Data, Inc.
Chemistry · 10d
Cleared Mar 05, 2004
ALLOMATRIX MODEL# 86
K020895 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 717d
Cleared Mar 05, 2004
DYNESYS SPINAL SYSTEM
K031511 · NQP
Centerpulse Spine-Tech, Inc.
Orthopedic · 296d
Cleared Mar 05, 2004
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
K032278 · GXY
Ambu, Inc.
Neurology · 225d
Cleared Mar 05, 2004
COLONOSIGHT MODEL 510B
K032688 · FDF
Sightline Technologies , Ltd.
Gastroenterology & Urology · 189d
Cleared Mar 05, 2004
I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2
K033136 · LPL
Innova Vision, Inc.
Ophthalmic · 157d
Cleared Mar 05, 2004
PAJUNK MODULAR HANDLE INSTRUMENTS
K033249 · GCJ
Pajunk GmbH
General & Plastic Surgery · 150d
Cleared Mar 05, 2004
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002
K033410 · DXH
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 130d
Cleared Mar 05, 2004
NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
K033810 · HRY
Centerpulse Orthopedics, Inc.
Orthopedic · 88d
Cleared Mar 05, 2004
SPI CONTACT DENTAL IMPLANT
K034014 · DZE
Thommen Medical AG
Dental · 72d
Cleared Mar 05, 2004
TI CLIP APPLIER
K034029 · NJC
Gyrx, LLC
General & Plastic Surgery · 67d
Cleared Mar 05, 2004
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG...
K040095 · MVM
Immco Diagnostics, Inc.
Immunology · 45d
Cleared Mar 05, 2004
LABONE COCAINE METABOLITE MICRO-PLATE EIA
K040198 · DIO
Labone, Inc.
Toxicology · 36d
Cleared Mar 05, 2004
INTEGRAL HEMODIALYSIS CATHETER
K040260 · MSD
Arrow Int'L.
Gastroenterology & Urology · 30d
Cleared Mar 05, 2004
QSC-127-INT SHOULDER ARRAY COIL SET
K040288 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Mar 05, 2004
CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY
K040405 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 17d
Cleared Mar 05, 2004
SIMIDUR SUPERIOR
K040436 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 15d
Cleared Mar 05, 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K040446 · LJS
AngioDynamics, Inc.
General Hospital · 14d
Cleared Mar 05, 2004
LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
K040455 · JJX
Cliniqa Corporation
Chemistry · 11d
Cleared Mar 04, 2004
SYNTHES VENTROFIX MIS SYSTEM
K031100 · KWQ
Synthes (Usa)
Orthopedic · 332d