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
96385–96408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1996
CARBAMAZEPINE FLEX REAGENT CARTRIDGE
K962820 · KLT
Dade Intl., Inc.
Toxicology · 56d
Cleared Sep 13, 1996
VENIPUNCTURE KIT
K963070 · FPA
Miller Products and Services
General Hospital · 37d
Cleared Sep 13, 1996
SHEATH, ELECTROSURGICAL PENCIL
K963088 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 36d
Cleared Sep 13, 1996
VANCOMYCIN FLEX REAGENT CARTRIDGE
K963267 · LEH
Dade Intl., Inc.
Toxicology · 24d
Cleared Sep 13, 1996
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
K963275 · LLL
Immuno Concepts, Inc.
Immunology · 24d
Cleared Sep 12, 1996
E100A PULSE OXIMETER FINGER SENSOR/PROBE
K954168 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 373d
Cleared Sep 12, 1996
MIZUHO RADIOLUCENT HEAD FRAME
K955012 · HBL
Mizuho America, Inc.
Neurology · 316d
Cleared Sep 12, 1996
POSITRON COINCIDENCE DETECTION
K960192 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 240d
Cleared Sep 12, 1996
DMS-9000
K960836 · LRJ
O.R. Solutions, Inc.
General Hospital · 196d
Cleared Sep 12, 1996
FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL...
K960965 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 185d
Cleared Sep 12, 1996
BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED...
K961039 · FJI
Dayspring Medical, Inc.
Gastroenterology & Urology · 182d
Cleared Sep 12, 1996
SMART-TENS, MODEL 456
K961376 · GZJ
Bio-Medical Research, Ltd.
Neurology · 157d
Cleared Sep 12, 1996
PERCUTANEOUS INTRODUCER SET
K961466 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 148d
Cleared Sep 12, 1996
BIPORE BALLOON DILATATION CATHETER
K961980 · LIT
Bipore, Inc.
Cardiovascular · 115d
Cleared Sep 12, 1996
CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB...
K962218 · MGQ
Carrington Laboratories, Inc.
General & Plastic Surgery · 94d
Cleared Sep 12, 1996
UNICAP 100
K962274 · DHB
Pharmacia, Inc.
Immunology · 91d
Cleared Sep 12, 1996
GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10
K962329 · FMF
Global Medical Prods, Inc.
General Hospital · 87d
Cleared Sep 12, 1996
EBS (ESPE BONDING SYSTEM)
K962428 · KLE
Espe GmbH & Co. Kg.
Dental · 80d
Cleared Sep 12, 1996
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING...
K962495 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 78d
Cleared Sep 12, 1996
DERMAPLEX HYDROGEL WOUND DRESSING
K962513 · MGQ
Maxxim Medical
General & Plastic Surgery · 77d
Cleared Sep 12, 1996
DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A
K962520 · FLL
Mesure Technology
General Hospital · 77d
Cleared Sep 12, 1996
E-TYPE CONTRA ANGLE NAC-E
K962540 · EGS
Nsk Nakanishi, Inc.
Dental · 76d
Cleared Sep 12, 1996
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
K962836 · DHR
Hemagen Diagnostics, Inc.
Immunology · 52d
Cleared Sep 12, 1996
NEOSONO
K962853 · LQY
L.S. Scientific
Dental · 52d