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
87865–87888 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1998
PREMIER CRYPTOSPORIDIUM
K982764 · MHJ
Meridian Diagnostics, Inc.
Microbiology · 119d
Cleared Dec 03, 1998
ELECTROSURGICAL INFLATABLE BASKET ELECTRODES
K983116 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 90d
Cleared Dec 03, 1998
IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY,...
K983128 · JDI
Implex Corp.
Orthopedic · 86d
Cleared Dec 03, 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K983165 · HWC
Osteonics Corp.
Orthopedic · 84d
Cleared Dec 03, 1998
NELSON RESURFACING HEAD
K983452 · KXA
Biomet, Inc.
Orthopedic · 64d
Cleared Dec 03, 1998
DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS
K983583 · KWP
Depuy, Inc.
Orthopedic · 51d
Cleared Dec 03, 1998
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
K984071 · JJX
Bio-Rad
Chemistry · 17d
Cleared Dec 02, 1998
ERADIC-ALL
K981171 · EIA
Theratechnologies, Inc.
Dental · 245d
Cleared Dec 02, 1998
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF...
K981881 · DZL
Doctor'S Research Group, Inc.
Dental · 188d
Cleared Dec 02, 1998
VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR,...
K982212 · GEI
Synergetics, Inc.
General & Plastic Surgery · 162d
Cleared Dec 02, 1998
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
K983026 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 93d
Cleared Dec 02, 1998
ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE
K983279 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 75d
Cleared Dec 02, 1998
BARRON MICROKERATOME SYSTEM, MODEL B2000
K983317 · HNO
Barron Precision Instruments, LLC
Ophthalmic · 72d
Cleared Dec 02, 1998
DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
K983491 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 58d
Cleared Dec 02, 1998
150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH
K983710 · JDI
Biomet, Inc.
Orthopedic · 42d
Cleared Dec 02, 1998
OSTEONICS RESTORATION HA HIP STEMS
K983870 · MEH
Osteonics Corp.
Orthopedic · 30d
Cleared Dec 01, 1998
CAIRD TECHNOLOGY SPIROMETER
K971336 · BZG
Caird Technology
Anesthesiology · 600d
Cleared Dec 01, 1998
VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE
K974259 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 383d
Cleared Dec 01, 1998
PERIPHERAL VASCULAR DILATOR
K974617 · DRE
Endovascular Instruments, Inc.
Cardiovascular · 355d
Cleared Dec 01, 1998
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM
K983065 · LFL
Mentor Corp.
General & Plastic Surgery · 90d
Cleared Dec 01, 1998
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
K983072 · OLV
Nihon Kohden America, Inc.
Neurology · 90d
Cleared Dec 01, 1998
DELIVERY SHEATH
K983415 · FED
Conway Stuart Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Dec 01, 1998
ABBOTT ARCHEITECT TOTAL B-HCG
K983424 · DHA
Abbott Laboratories
Chemistry · 63d
Cleared Dec 01, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS...
K983503 · CEO
Boehringer Mannheim Corp.
Chemistry · 56d