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
93265–93288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1997
STERILE FLEXOFILE FILES AND INSTRUMENTS
K971606 · EFA
Dentsply Intl.
Dental · 33d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF...
K971788 · DHR
Beckman Instruments, Inc.
Immunology · 20d
Cleared Jun 03, 1997
LUMAX CYSTOMETRY ADMINISTRATION TUBE SET
K971911 · FEN
Medamicus, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 02, 1997
VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR
K963571 · FMI
Vygon Corp.
General Hospital · 270d
Cleared Jun 02, 1997
OPTICAL TRACKING SYSTEM (OTS)
K964801 · HAW
Radionics Software Applications, Inc.
Neurology · 185d
Cleared Jun 02, 1997
PERIPHERALLY INSERTED CENTRAL CATHETER
K964929 · LJS
B.Braun Medical, Inc.
General Hospital · 175d
Cleared Jun 02, 1997
QUANTA LITE IGA GLIADIN ELISA
K964986 · MST
Inova Diagnostics, Inc.
Immunology · 171d
Cleared Jun 02, 1997
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
K970446 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 117d
Cleared Jun 02, 1997
CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH
K970767 · HIS
Custom Services Intl., Inc.
Obstetrics & Gynecology · 91d
Cleared Jun 02, 1997
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE
K970792 · HIS
Titan Condoms
Obstetrics & Gynecology · 90d
Cleared Jun 02, 1997
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM
K970942 · GWQ
Physiometrix, Inc.
Neurology · 80d
Cleared Jun 02, 1997
SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER
K971085 · LJS
B.Braun Medical, Inc.
General Hospital · 69d
Cleared Jun 02, 1997
SILICONE PUTTY EAR PLUGS
K971517 · EWD
Bentec Medical, Inc.
Ear, Nose, Throat · 38d
Cleared Jun 02, 1997
ELECSYS FERRITIN
K971833 · JMG
Boehringer Mannheim Corp.
Immunology · 14d
Cleared May 30, 1997
COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
K951927 · BSO
Csen , Ltd.
Anesthesiology · 767d
Cleared May 30, 1997
DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
K951928 · BSP
Csen , Ltd.
Anesthesiology · 766d
Cleared May 30, 1997
IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT
K964341 · MST
Immco Diagnostics, Inc.
Immunology · 211d
Cleared May 30, 1997
IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT
K964344 · MST
Immco Diagnostics, Inc.
Immunology · 211d
Cleared May 30, 1997
QUANTA LITE IGG GLIADIN ELISA
K964985 · MST
Inova Diagnostics, Inc.
Immunology · 168d
Cleared May 30, 1997
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
K970491 · EGJ
Empi
Physical Medicine · 109d
Cleared May 30, 1997
MDX 2000, DIGITAL ANALYZER
K970824 · JOY
Shotwell & Carr, Inc.
Hematology · 85d
Cleared May 30, 1997
QUIKSTRIP ONE STEP AMPHETAMINE TEST
K971218 · DKZ
Drial Consultants, Inc.
Toxicology · 58d
Cleared May 30, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K971376 · JWY
Dade Microscan, Inc.
Microbiology · 46d
Cleared May 30, 1997
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
K971691 · DIF
Bio-Rad
Toxicology · 23d