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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
135001–135024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1988
MODEL BIOSTAR
K882062 · HCC
Targus Concepts
Neurology · 32d
Cleared Jun 17, 1988
SPINAL DISTRACTORS, SPANNERS
K882069 · LXH
Karlin Technology, Inc.
Orthopedic · 31d
Cleared Jun 17, 1988
ORTHOPAEDIC AND SPINAL RING CURRETTES
K882072 · JXH
Karlin Technology, Inc.
Neurology · 31d
Cleared Jun 17, 1988
MICRODISCECTOMY CURRETTES
K882077 · LXH
Karlin Technology, Inc.
Orthopedic · 31d
Cleared Jun 17, 1988
SURGICAL DUCT CLAMP (VINE)
K882169 · GDJ
Henley Intl.
General & Plastic Surgery · 24d
Cleared Jun 17, 1988
RX ASPEN
K882170 · EJH
Jeneric/Pentron, Inc.
Dental · 24d
Cleared Jun 17, 1988
NEOTECH UNIVERSAL ADAPTER
K882203 · BZA
Neotech Products, Inc.
Anesthesiology · 23d
Cleared Jun 17, 1988
1/2 CM REAR TIP EXTENDER (RTE)
K882297 · FHN
American Medical Systems, Inc.
Gastroenterology & Urology · 15d
Cleared Jun 16, 1988
ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201
K874366 · DTB
Cordis Leads, Inc.
Cardiovascular · 237d
Cleared Jun 16, 1988
WITT BIOMEDICAL VX-80
K880258 · DXG
Witt Biomedical Corporation
Cardiovascular · 146d
Cleared Jun 16, 1988
AT EASE STRESS PAD
K880454 · EYQ
Hospital Specialty Co.
Gastroenterology & Urology · 135d
Cleared Jun 16, 1988
B. CAT CONFIRM
K880694 · JTO
Scott Laboratories, Inc.
Microbiology · 115d
Cleared Jun 16, 1988
OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701C
K881269 · DXN
Omron Electronics, Inc.
Cardiovascular · 84d
Cleared Jun 16, 1988
SHERIDAN ELECTROSURGERY PROTECTION FILTER
K881293 · BZT
Sheridan Catheter Corp.
Anesthesiology · 80d
Cleared Jun 16, 1988
BLOOD/SOLUTION SET W/PRESSURE PUMP
K881321 · FPA
Baxter Healthcare Corp
General Hospital · 79d
Cleared Jun 16, 1988
SL02 OXYGEN ANALYZER
K881472 · CCL
Salter Labs
Anesthesiology · 70d
Cleared Jun 16, 1988
SL01 OXYGEN ANALYZER
K881473 · CCL
Salter Labs
Anesthesiology · 70d
Cleared Jun 16, 1988
VEOLAR VENTILATOR
K881482 · CBK
Hamilton Medical, Inc.
Anesthesiology · 69d
Cleared Jun 16, 1988
PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM
K881514 · BSK
Hall Laboratories, Inc.
Anesthesiology · 66d
Cleared Jun 16, 1988
UROLOGICAL CATHETER
K881646 · KOD
Coeur Laboratories, Inc.
Gastroenterology & Urology · 62d
Cleared Jun 16, 1988
HUMID-VENT 2 S FLEX
K881656 · BYD
Gibeck Respiration
Anesthesiology · 62d
Cleared Jun 16, 1988
BIOTROL CREATININE H.P. REAGENT
K881856 · CGX
Biotrol, USA, Inc.
Chemistry · 44d
Cleared Jun 16, 1988
SPARE MS 700 TENS ELECTRODE
K881871 · GXY
Lectec Corp.
Neurology · 44d
Cleared Jun 16, 1988
TENS ELECTRODE MODEL 238P
K881872 · GXY
Lectec Corp.
Neurology · 44d