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
130585–130608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1989
KENDALL CURITY OXYGEN NASAL CANNULA
K892435 · CAT
The Kendal Co.
Anesthesiology · 63d
Cleared Jun 12, 1989
REPRO-MED NEONATE ASPIRATION SYSTEM
K892529 · BSY
Repro-Med Systems, Inc.
Anesthesiology · 62d
Cleared Jun 12, 1989
GEM II ORTHODONTIC BRACKET
K892704 · EJF
Ormco Corp.
Dental · 59d
Cleared Jun 12, 1989
ARGELITE 54B
K892811 · EJT
Argen Precious Metals, Inc.
Dental · 56d
Cleared Jun 12, 1989
OPHTHASCAN 'S' MINI-A
K893035 · IYO
Biophysic Medical, Inc.
Radiology · 49d
Cleared Jun 12, 1989
NO-MIX 30 ORTHODONTIC BONDING SYSTEMS
K893037 · DYH
American Orthodontics
Dental · 49d
Cleared Jun 12, 1989
ARGENCO W+
K893227 · EJT
Argen Precious Metals, Inc.
Dental · 46d
Cleared Jun 12, 1989
ALPHA SHOPPER
K893428 · ITI
Alpha Unlimited, Inc.
Physical Medicine · 41d
Cleared Jun 12, 1989
ALPHA CONDOR
K893429 · INI
Alpha Unlimited, Inc.
Physical Medicine · 41d
Cleared Jun 12, 1989
HANDI-LIFT/VICTORY WHEELCHAIR LIFT
K893490 · ING
The Cheney Co.
Physical Medicine · 39d
Cleared Jun 12, 1989
SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS
K893503 · HFN
Laurel Medical Corp.
Obstetrics & Gynecology · 38d
Cleared Jun 12, 1989
HANDI PORCH ELEVATOR & LIBERTY WHEELCHAIR LIFT
K893544 · ING
The Cheney Co.
Physical Medicine · 39d
Cleared Jun 09, 1989
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · ETY
Storz Instrument Co.
Ear, Nose, Throat · 309d
Cleared Jun 09, 1989
MICRO-STRAIGHT POSTURE TRAINING DEVICE
K884976 · LZW
Mcdowell Ent., Inc.
Physical Medicine · 191d
Cleared Jun 09, 1989
ASSAYED CHOLINESTERASE CONTROL
K885282 · JJX
Actio, Inc.
Chemistry · 171d
Cleared Jun 09, 1989
QUIK-DOT TOXOPLASMOSIS
K890048 · LLA
Ampcor, Inc.
Microbiology · 154d
Cleared Jun 09, 1989
SENSITITRE AUTO ID PLATE AP80
K890057 · LQM
Radiometer America, Inc.
Microbiology · 154d
Cleared Jun 09, 1989
TDP INFRARED HEAT LAMP
K890556 · ILY
Toxicology Professionals, Inc.
Physical Medicine · 123d
Cleared Jun 09, 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
K891082 · LZO
Depuy, Inc.
Orthopedic · 100d
Cleared Jun 09, 1989
CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER
K891083 · LZO
Depuy, Inc.
Orthopedic · 100d
Cleared Jun 09, 1989
TEGASORB(TM) ULCER DRESSING, #90-XXX
K891288 · FRO
3M Company
General & Plastic Surgery · 91d
Cleared Jun 09, 1989
CLIRANS HOLLOW FIBER HEMODIALYZER (WET)
K891477 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 85d
Cleared Jun 09, 1989
ENAMEL MICROABRASION COMPOUND
K891536 · EJR
Premier Dental Products Co.
Dental · 84d
Cleared Jun 09, 1989
DIALBUMIN
K891544 · JIR
Exocell, Inc.
Chemistry · 84d