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
133585–133608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1988
IRRIGATION KIT
K883506 · KYZ
L H M Ent., Inc.
General Hospital · 118d
Cleared Dec 13, 1988
CATHETER, INTRAUTERINE AND INTRODUCER
K883832 · KXO
Telos Medical Corp.
Obstetrics & Gynecology · 95d
Cleared Dec 13, 1988
MANUAL PERCUSSOR CUPS
K883899 · BYI
Medical Components, Inc.
Anesthesiology · 89d
Cleared Dec 13, 1988
CFX 625
K883976 · IZO
Fischer Imaging Corp.
Radiology · 84d
Cleared Dec 13, 1988
SANIFIX
K883983 · KGX
Iberhospitex, S.A.
General & Plastic Surgery · 84d
Cleared Dec 13, 1988
COATEST PROTEIN C
K884058 · GGP
Kabivitrum, Inc.
Hematology · 78d
Cleared Dec 13, 1988
TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE
K884198 · DQX
Target Therapeutics
Cardiovascular · 68d
Cleared Dec 13, 1988
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · KRB
Abbott Laboratories
Cardiovascular · 61d
Cleared Dec 13, 1988
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
K884543 · CBP
Sechrist Industries, Inc.
Anesthesiology · 43d
Cleared Dec 13, 1988
WASHER 500 MICROELISA SYSTEM
K884695 · JTC
Organon Teknika Corp.
Microbiology · 34d
Cleared Dec 12, 1988
SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT
K875187 · IYO
Shimadzu Corp.
Radiology · 356d
Cleared Dec 12, 1988
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
K882289 · DSY
Aries Medical, Inc.
Cardiovascular · 194d
Cleared Dec 12, 1988
MIKADO AC 405
K883837 · CAW
Ivex Medical, Inc.
Anesthesiology · 91d
Cleared Dec 12, 1988
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.
K883888 · DXK
Advanced Biosearch Assn.
Cardiovascular · 88d
Cleared Dec 12, 1988
FLO-GARD VP
K884014 · FRN
Baxter Healthcare Corp
General Hospital · 81d
Cleared Dec 12, 1988
TX-7 (TENS) (IC-1107)
K884210 · GZJ
Oms Medical Supplies, Inc.
Neurology · 67d
Cleared Dec 12, 1988
WOODEN SPECTACLE FRAMES
K884272 · HQZ
Woodwave
Ophthalmic · 61d
Cleared Dec 12, 1988
CONTROL SYRINGE
K884497 · FMF
Professional Medical Services
General Hospital · 48d
Cleared Dec 12, 1988
UV AIR STERILIGHT
K884579 · FRA
Allseasons Environmental Control, Inc.
General Hospital · 39d
Cleared Dec 12, 1988
ROLLS 3000 SERIES WHEELCHAIR (YOUTHMOBILE)
K884931 · IOR
Invacare Corp.
Physical Medicine · 14d
Cleared Dec 12, 1988
INVACARE YOUTHMOBILE 5000 SERIES WHEELCHAIR
K884932 · IOR
Invacare Corp.
Physical Medicine · 14d
Cleared Dec 09, 1988
IDS-1600 SAMPLE HANDLING SYSTEM
K883470 · JQW
Baxter Healthcare Corp
Chemistry · 116d
Cleared Dec 09, 1988
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
K883817 · CGA
Boehringer Mannheim Corp.
Chemistry · 92d
Cleared Dec 09, 1988
ND:YAG LASER SPECTACLES, MST MODEL #YLS-5
K883839 · KYP
Marlo Surgical Technology
General Hospital · 88d