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
96697–96720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1996
TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60
K961281 · CDT
Diagnostic Chemicals , Ltd.
Chemistry · 135d
Cleared Aug 16, 1996
PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE
K961357 · FLL
Intelligent Product Limited Co.
General Hospital · 130d
Cleared Aug 16, 1996
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
K961837 · BTR
Rusch Intl.
Anesthesiology · 95d
Cleared Aug 16, 1996
MICROLAB 4000, MICROLAB 4200
K961896 · JQW
Hamilton Co.
Chemistry · 92d
Cleared Aug 16, 1996
THE BIOPLATE FIXATION SYSTEM
K961976 · JEY
Biomedics
Dental · 88d
Cleared Aug 16, 1996
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K962150 · LTT
Dade Intl., Inc.
Microbiology · 73d
Cleared Aug 16, 1996
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
K962280 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 64d
Cleared Aug 16, 1996
SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
K962762 · JJJ
Biotraces, Inc.
Chemistry · 31d
Cleared Aug 16, 1996
SEIRIN ACUPUNCTURE NEEDLES
K962809 · MQX
Seirin-America, Inc.
General Hospital · 29d
Cleared Aug 16, 1996
ACTIVE ANDROSTENEDIONE EIA
K963002 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 14d
Cleared Aug 15, 1996
ANDELA DYNAMIC COOLING DEVICE
K951033 · IMD
Candela Laser Corp.
Physical Medicine · 528d
Cleared Aug 15, 1996
ACCESS (POWERCLAVE)
K954736 · FLE
Mdt Biologic Co.
General Hospital · 304d
Cleared Aug 15, 1996
QUIX RAPID CHOLERA STRIP TEST
K954995 · GSQ
Guardian Scientific, Corp.
Microbiology · 289d
Cleared Aug 15, 1996
DINAMAP SELECT MULTI-PARAMETER SYSTEM
K955113 · DPS
Johnson & Johnson Medical, Inc.
Cardiovascular · 281d
Cleared Aug 15, 1996
GRAYCO POCKET PUMP
K955507 · BTM
Grayco, Inc.
Anesthesiology · 258d
Cleared Aug 15, 1996
NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY
K960584 · HQD
Novavision, Inc.
Ophthalmic · 185d
Cleared Aug 15, 1996
POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM
K960841 · LYY
Boston Medical Corp.
General Hospital · 170d
Cleared Aug 15, 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960940 · HWC
Linvatec Corp.
Orthopedic · 160d
Cleared Aug 15, 1996
ENDOCARE ELECTORNIC THERMOMETER SYSTEM
K961365 · FLL
Endocare, Inc.
General Hospital · 128d
Cleared Aug 15, 1996
ARGON CURING LASER
K961682 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 106d
Cleared Aug 15, 1996
QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET
K961912 · JJY
Consolidated Technologies, Inc.
Immunology · 90d
Cleared Aug 15, 1996
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
K961915 · BZD
Respironics, Inc.
Anesthesiology · 90d
Cleared Aug 15, 1996
BERENSTEIN COIL
K961923 · HCG
Target Therapeutics
Neurology · 90d
Cleared Aug 15, 1996
MODEL 2188 CORONARY SINUS LEAD.
K961936 · DTB
Medtronic Vascular
Cardiovascular · 87d