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
130537–130560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1989
LATEX EXAMINATION GLOVES
K893166 · LYY
Gulfwin Holding Sdn. Bhd.
General Hospital · 61d
Cleared Jun 14, 1989
LATEX EXAMINATION GLOVES
K893266 · LYY
Yi-Gang Machinery & Engineering Co.,...
General Hospital · 58d
Cleared Jun 14, 1989
ARGELITE 50 (DENTAL ALLOY FOR PORCELAIN APPLI.)
K893345 · EJT
Argen Precious Metals, Inc.
Dental · 51d
Cleared Jun 14, 1989
ARGENCO 71 TYPE II DENTAL GOLD ALLOY
K893381 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 63 TYPE III DENTAL GOLD ALLOY
K893382 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 75 TYPE III DENTAL GOLD ALLOY
K893383 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 83 TYPE I DENTAL GOLD ALLOY
K893384 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 77 TYPE II DENTAL GOLD ALLOY
K893385 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 62 TYPE III DENTAL GOLD ALLOY
K893386 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 40 TYPE III DENTAL GOLD ALLOY
K893413 · EJT
Argen Precious Metals, Inc.
Dental · 43d
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