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
123481–123504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 1991
ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER
K903136 · DRF
Arzco Medical Electronics, Inc.
Cardiovascular · 185d
Cleared Jan 18, 1991
OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
K903186 · DXY
Telectronics Pacing Systems, Inc.
Cardiovascular · 183d
Cleared Jan 18, 1991
GASTRO-INTESTINAL ACCU-CULSHURE TM
K903638 · LIO
Medical Laboratory Automation...
Microbiology · 158d
Cleared Jan 18, 1991
SYNAPS (TM)
K903828 · GZJ
Henley Intl.
Neurology · 150d
Cleared Jan 18, 1991
MTS FEMORAL HIP SYSTEM
K903877 · KWL
3M Company
Orthopedic · 149d
Cleared Jan 18, 1991
COMPACT MONITOR SMK 210,211,230,231,240
K903917 · DSP
Ppg Hellige B.V.
Cardiovascular · 147d
Cleared Jan 18, 1991
VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
K904222 · GWL
Telediagnostic Systems, Inc.
Neurology · 127d
Cleared Jan 18, 1991
FREE PROTEIN S REAGENT CAT. NO. 5363
K904247 · GGP
Helena Laboratories
Hematology · 126d
Cleared Jan 18, 1991
FOCUS T41,T41F,T43, T43F,T44F
K904255 · DTB
Elamedical
Cardiovascular · 123d
Cleared Jan 18, 1991
KODAK SURECELL(TM) STREP A CONTROL FLUID SET
K904589 · GTY
Eastman Kodak Company
Microbiology · 101d
Cleared Jan 18, 1991
BUTTON REPLACEMENT GASTROSTOMY DEVICE
K904779 · KGC
C.R. Bard, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 18, 1991
OPTEC 2300 AFVT, ARMED FORCES VISION TESTER
K904828 · HKO
Stereo Optical Co., Inc.
Ophthalmic · 86d
Cleared Jan 18, 1991
PATIENT EXAMINATION GLOVES
K905031 · LYZ
Phoenix Medical Technology, Inc.
General Hospital · 72d
Cleared Jan 18, 1991
COMFORT SLEEVED ALL SILICONE FOLEY CATHETER
K905042 · EZL
Rochester Medical Corp.
Gastroenterology & Urology · 72d
Cleared Jan 18, 1991
PM GLOVE
K905055 · LYZ
Pm Gloves, Inc.
General Hospital · 72d
Cleared Jan 18, 1991
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
K905229 · FGE
Arrow Intl., Inc.
Gastroenterology & Urology · 59d
Cleared Jan 18, 1991
ELITE 5000
K905501 · IXR
Fischer Imaging Corp.
Radiology · 42d
Cleared Jan 18, 1991
ILLUMINA MODEL 780 CO2 LASER SYSTEM
K905637 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 32d
Cleared Jan 18, 1991
ALADERM
K905678 · LYY
Aladan Corp.
General Hospital · 30d
Cleared Jan 18, 1991
ZENITH COX FLEXION CHIROPRACTIC TABLE
K905685 · INQ
Williams Manufacturing Co.
Physical Medicine · 30d
Cleared Jan 18, 1991
GENNY DENNY IV SHIELD
K905735 · KMK
Tadco, Inc.
General Hospital · 25d
Cleared Jan 18, 1991
ATI MEDICAL COMFORT PLUS CPM PAD
K910026 · BXB
Ati Medical, Inc.
Physical Medicine · 15d
Cleared Jan 18, 1991
ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT
K910149 · BXB
Dyna Flex, Intl.
Physical Medicine · 4d
Cleared Jan 18, 1991
ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT
K910151 · BXB
Dyna Flex, Intl.
Physical Medicine · 4d