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
92761–92784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1997
CHROMOPHARE
K965130 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 203d
Cleared Jul 14, 1997
ACS DIGITOXIN
K970546 · LFM
Chiron Diagnostics Corp.
Chemistry · 152d
Cleared Jul 14, 1997
MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR
K970763 · DQA
Medical Data Electronics
Anesthesiology · 133d
Cleared Jul 14, 1997
LATEX EXAMINATION GLOVES
K970770 · LYY
Oon Corp. Resources
General Hospital · 133d
Cleared Jul 14, 1997
TARGOBEAM
K970819 · JAK
Ferguson Medical
Radiology · 131d
Cleared Jul 14, 1997
FG INFUSION CATHETER
K971306 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 97d
Cleared Jul 14, 1997
SUNGLASSES
K971385 · HQY
Kosway Industries Co., Ltd.
Ophthalmic · 91d
Cleared Jul 14, 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K971393 · LJZ
Immunoprobe, Inc.
Microbiology · 96d
Cleared Jul 14, 1997
GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN...
K971395 · DQX
Target Therapeutics
Neurology · 90d
Cleared Jul 14, 1997
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
K971474 · DTE
Medtronic Vascular
Cardiovascular · 82d
Cleared Jul 14, 1997
MENTOR GEMINI HEMOSTATIC ERASER
K971538 · HQO
Mentor Ophthalmics, Inc.
Ophthalmic · 77d
Cleared Jul 14, 1997
PROVEST-PROTECTIVE RESTRAINT
K971561 · FMQ
Jemm Medical Products
General Hospital · 76d
Cleared Jul 14, 1997
CREATINE KINASE-MB REAGENT SET
K971566 · CGS
Horizon Diagnostics, Inc.
Chemistry · 76d
Cleared Jul 14, 1997
VISTA BRITE TIP CATHETERS
K971572 · DQY
Cordis Corp.
Cardiovascular · 75d
Cleared Jul 14, 1997
ALCON CONTACT LENS CASE
K971618 · LRX
Alcon Laboratories
Ophthalmic · 73d
Cleared Jul 14, 1997
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER
K971646 · DQO
Cordis Corp.
Cardiovascular · 70d
Cleared Jul 14, 1997
SNT STEREOTACTIC LOCALIZATION SYSTEM
K971675 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 68d
Cleared Jul 14, 1997
ETEST FOR LEVOFLOXACIN
K971697 · JWY
Ab Biodisk
Microbiology · 67d
Cleared Jul 14, 1997
ECHOVACS
K971776 · LLZ
Vmi Technologies
Radiology · 62d
Cleared Jul 14, 1997
AUTOMATED CHAMBER MAINTENANCE MODULE
K971795 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 60d
Cleared Jul 14, 1997
QUIKSTRIP ONE STEP COCAINE TEST
K971926 · DIO
Drial Consultants, Inc.
Toxicology · 48d
Cleared Jul 14, 1997
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE
K971945 · KGO
Tillotson Healthcare Corp.
General Hospital · 48d
Cleared Jul 14, 1997
THYROGLOBULIN ASSAY SYSTEM
K972190 · JZO
American Laboratory Products Co., Ltd.
Immunology · 56d
Cleared Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
K972286 · GJT
Universal Reagents, Inc.
Hematology · 25d