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
150577–150600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1984
TPN/HYPERALIMENTATION TRAY
K842644 · FRG
Deroyal Industries, Inc.
General Hospital · 121d
Cleared Nov 08, 1984
SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT
K842690 · FFT
Synectics AB
Gastroenterology & Urology · 121d
Cleared Nov 08, 1984
DORR HIP PROSTHESIS, ACETABULAR COMPON
K842893 · JDL
Carbomedics, Inc.
Orthopedic · 108d
Cleared Nov 08, 1984
AQUAPHOR R GAUZE
K842967 · FRO
Beiersdorf, Inc.
General & Plastic Surgery · 104d
Cleared Nov 08, 1984
ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND
K843139 · NAD
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 91d
Cleared Nov 08, 1984
ISOLATE ADHESIVE BANDAGE FOR DRY WOUND
K843140 · NAD
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 91d
Cleared Nov 08, 1984
STENOSCOP
K843235 · JAA
Cgr Medical Corp.
Radiology · 84d
Cleared Nov 08, 1984
KETRONIC MEDAX - N
K843288 · IYX
Ketronic, Inc.
Radiology · 79d
Cleared Nov 08, 1984
ASC 4080 SYSTEM
K843634 · IKE
Atlantis Scientific Corp.
Physical Medicine · 52d
Cleared Nov 08, 1984
DUAL CHENNEL BRAIN ACTIVITY MONITOR
K843808 · OLT
Datex Division Instrumentarium Corp.
Neurology · 42d
Cleared Nov 08, 1984
TRANSFERSCREEN II
K843857
Erich Jaeger, Inc.
Cardiovascular · 38d
Cleared Nov 08, 1984
SOLAR-GOLD UV-A BY EOS
K843902 · FTC
Eos-Werke, Gunther GmbH
General & Plastic Surgery · 36d
Cleared Nov 08, 1984
ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS
K843966 · HQB
American Medical Optics
Ophthalmic · 28d
Cleared Nov 08, 1984
LANCE BLADES & SCALPELS
K844001 · GES
Perry, Div.
General & Plastic Surgery · 27d
Cleared Nov 08, 1984
HU-FRIEDY IMS CASSETTE SYSTEM
K844002 · FSM
Hu-Friedy Mfg. Co., Inc.
Radiology · 27d
Cleared Nov 08, 1984
ARM-A-VIAL LV HEATER-BREATHING SYS
K844005 · BZE
Armour Pharmaceutical Co.
Anesthesiology · 27d
Cleared Nov 08, 1984
COSGROVE MITRAL VALVE RETRACTOR
K844177 · GAD
Kapp Surgical Instrument, Inc.
General & Plastic Surgery · 14d
Cleared Nov 07, 1984
COMFEEL PASTE
K840362
Coloplast A/S
General & Plastic Surgery · 286d
Cleared Nov 07, 1984
COMFEEL ULCUS SHEET
K840438 · FRO
Coloplast A/S
General & Plastic Surgery · 280d
Cleared Nov 07, 1984
MODEL 305AA PORTABLE LASER
K841781 · GEX
Laser Spectrum, Inc.
General & Plastic Surgery · 191d
Cleared Nov 07, 1984
HYDROXYAPATITE
K842718 · LYC
Depuy, Inc.
Dental · 117d
Cleared Nov 07, 1984
SKIN-LITE
K843300 · KMF
Guardian Chemical
General & Plastic Surgery · 76d
Cleared Nov 07, 1984
THE BIBICURE SYS DERMEPIL NATURAL HAIR
K843543
Les Entreprises Bibi, Inc.
General & Plastic Surgery · 61d
Cleared Nov 07, 1984
PORTABLE OXYGEN UNIT
K843691 · CAW
B & F Medical Products, Inc.
Anesthesiology · 49d