FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131137–131160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1989
PERSONAL AMPLIFIER MODEL ULTRA HELIX
K893433 · ESD
Electone, Inc.
Ear, Nose, Throat · 43d
Cleared Jun 14, 1989
ARGENCO 20 TYPE III DENTAL GOLD ALLOY
K893434 · EJT
Argen Precious Metals, Inc.
Dental · 43d
Cleared Jun 14, 1989
ARGENCO 50 TYPE III DENTAL GOLD ALLOY
K893441 · EJT
Argen Precious Metals, Inc.
Dental · 42d
Cleared Jun 14, 1989
ARGENCO 58 TYPE III DENTAL GOLD ALLOY
K893442 · EJT
Argen Precious Metals, Inc.
Dental · 42d
Cleared Jun 14, 1989
ARGENCO 60 TYPE III DENTAL GOLD ALLOY
K893443 · EJT
Argen Precious Metals, Inc.
Dental · 42d
Cleared Jun 14, 1989
ARGENCO 46 TYPE III DENTAL GOLD ALLOY
K893444 · EJT
Argen Precious Metals, Inc.
Dental · 42d
Cleared Jun 13, 1989
HEMAVIEW DARKFIELD MICROSCOPE SYSTEM
K885091 · IBM
Technalysis, Inc.
Pathology · 183d
Cleared Jun 13, 1989
RF-100 MONITOR, RF-P-2.5, RF-P-5, RF-P-7.5 PROBES
K885211 · IYN
Rf Design Assoc., Inc.
Radiology · 181d
Cleared Jun 13, 1989
CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS
K885279 · FRO
Beiersdorf, Inc.
General & Plastic Surgery · 172d
Cleared Jun 13, 1989
DANEK RING FIXATOR (DRF)
K890814 · KTT
Danek Medical, Inc.
Orthopedic · 117d
Cleared Jun 13, 1989
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
K891680 · JJY
Bio-Rad
Immunology · 84d
Cleared Jun 13, 1989
ROBICSEK INTRACARDIAC SUCTION WAND
K891906 · DTS
Gish Biomedical, Inc.
Cardiovascular · 78d
Cleared Jun 13, 1989
DANAM VECTOR-8+
K892205 · GKZ
Danam Electronics
Hematology · 71d
Cleared Jun 13, 1989
AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY
K892645 · KJF
Amicon, Inc.
Pathology · 62d
Cleared Jun 13, 1989
SUPER DUO
K892802 · JWZ
Mercia Diagnostics , Ltd.
Microbiology · 57d
Cleared Jun 13, 1989
HAEMOPHILUS TEST MEDIUM (AGAR)
K892928 · JSO
Remel Co.
Microbiology · 53d
Cleared Jun 13, 1989
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
K893439 · LFJ
Medical Components, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 13, 1989
IRISTAIN FORMULA 2, PARTS 1 AND 2
K893530 · JTS
Intl. Remote Imaging Systems
Pathology · 36d
Cleared Jun 13, 1989
INSTANT EOSIN-AQUEOUS
K893663 · HYB
Shandon, Inc.
Pathology · 29d
Cleared Jun 12, 1989
RESUBMITTAL OF MI 1000C MICROIMAGER
K881979 · JOP
Ausonics Pty , Ltd.
Cardiovascular · 396d
Cleared Jun 12, 1989
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
K884250 · LCJ
Mentor Corp.
General & Plastic Surgery · 244d
Cleared Jun 12, 1989
ADVENT VENTILATOR
K884793 · CBK
Ohmeda Medical
Anesthesiology · 208d
Cleared Jun 12, 1989
MODEL 1010, CY-MET
K884910 · BZK
Cybermedic, Inc.
Anesthesiology · 199d
Cleared Jun 12, 1989
CM 7000MR
K890010 · CAP
Trudell Medical
Anesthesiology · 160d