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
159793–159816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1982
NAGASHIMA NX-150F LIGHT SOURCE UNIT
K821710 · EQN
Kelleher Corp.
Ear, Nose, Throat · 16d
Cleared Jun 25, 1982
AM-40 SYSTEM
K821715 · EFB
American Midwest
Dental · 15d
Cleared Jun 25, 1982
PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000
K821720 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 15d
Cleared Jun 25, 1982
J. MORITA FLEX M-3 TORX HARDPIECE
K821739 · EKX
Pacific Dental Corp.
Dental · 11d
Cleared Jun 25, 1982
FRASER HARLAKE NITRONOX SCAVENGER
K821744 · CBN
Fraser Harlake, Inc.
Anesthesiology · 11d
Cleared Jun 25, 1982
IEC CENTRA 4 CENTRIFUGE
K821756 · JQC
International Equipment Co.
Chemistry · 10d
Cleared Jun 25, 1982
SERIES M PUSH-PULL INPUT COMPRESSION
K821760 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 10d
Cleared Jun 25, 1982
EMIT ST URINE METHAGUALONE CALIBRATOR
K821767 · DKB
Syva Co.
Toxicology · 10d
Cleared Jun 25, 1982
MACRO-VUE CARD TEST, AMIKACIN
K821771 · KLQ
Bd Becton Dickinson Vacutainer...
Toxicology · 9d
Cleared Jun 25, 1982
REGULAR MAXITHINS PADS & SUPER MAXITHINS
K821800 · HHD
Tampax, Inc.
Obstetrics & Gynecology · 18d
Cleared Jun 25, 1982
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
K821806 · DAK
Ortho Diagnostic Systems, Inc.
Immunology · 8d
Cleared Jun 25, 1982
ADVANCE C-REACTIVE PROTEIN (CRP) ASSAY
K821815
Syva Co.
Immunology · 7d
Cleared Jun 24, 1982
AMES/GILFORD OPTIMATE CLIN. CHEM & THER
K821583 · JJF
Gilford Instrument Laboratories, Inc.
Chemistry · 27d
Cleared Jun 24, 1982
GAMMADAB [125] FSH RADIOIMMUNAY KIT
K821611 · CGJ
Clinical Assays, Inc.
Chemistry · 22d
Cleared Jun 24, 1982
SURGICAL SCISSORS, SET OF 3
K821632 · FZT
Fred Sammons, Inc.
General & Plastic Surgery · 21d
Cleared Jun 24, 1982
E-Z UP ARTHERAPEDIC CHAIR
K821651 · INN
Medical Device Consultants, Inc.
Physical Medicine · 20d
Cleared Jun 24, 1982
PEDESTAL EXAMINING TABLE
K821665 · GDC
American Hamilton
General & Plastic Surgery · 20d
Cleared Jun 24, 1982
SINGLE USE NON-CONDUCTIVE CIRC. DISCON
K821667 · CAP
Vital Signs, Inc.
Anesthesiology · 17d
Cleared Jun 24, 1982
ARGYLE TARTAN I TRACHEAL TUBE
K821670 · BTR
Sherwood Medical Co.
Anesthesiology · 22d
Cleared Jun 24, 1982
AUTOPAK ESTRIOL TEST DELIVERY SYSTEM
K821678 · CGI
Micromedic Systems
Chemistry · 16d
Cleared Jun 24, 1982
HOLLISTER CATHETER ACCESS. PORT
K821680 · EXB
Hollister, Inc.
Gastroenterology & Urology · 16d
Cleared Jun 24, 1982
TRUNCAL ORTHOSIS
K821682 · IQE
Surgical Appliance Industries, Inc.
Physical Medicine · 16d
Cleared Jun 24, 1982
REAGENT FOR COULTER COUNTER MODEL 5+11
K821683 · GIF
Fisher Scientific Co., LLC
Hematology · 16d
Cleared Jun 24, 1982
MCSCP8PS WITH 'Y' HUB
K821684 · LFJ
Medical Components, Inc.
Gastroenterology & Urology · 16d