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
131185–131208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 09, 1989
LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030
K891574 · JGT
Em Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Jun 09, 1989
IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES
K891583 · FRN
Y
General Hospital · 81d
Cleared Jun 09, 1989
LISTERIA SELECTIVE ENRICHMENT MEDIUM
K891593 · JSI
Oxoid U.S.A., Inc.
Microbiology · 81d
Cleared Jun 09, 1989
ZAROLAN, DUALAN, TITAN AND SUPERON
K891698 · EBF
Dent Zar, Inc.
Dental · 81d
Cleared Jun 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891880 · LYY
Jextrag Schaffhausen AG
General Hospital · 73d
Cleared Jun 09, 1989
BICARBONATE
K891991 · KHS
Boehringer Mannheim Corp.
Chemistry · 73d
Cleared Jun 09, 1989
INNOFLUOR(TM) QUINIDINE REAGENT SET
K892208 · LBZ
Innotron of Oregon, Inc.
Toxicology · 67d
Cleared Jun 09, 1989
INNOFLUOR(TM) QUINDINE CALIBATOR SET
K892212 · DLJ
Innotron of Oregon, Inc.
Toxicology · 67d
Cleared Jun 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892288 · LYY
Ansell, Inc.
General Hospital · 64d
Cleared Jun 09, 1989
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
K892424 · CFF
Helena Laboratories
Chemistry · 60d