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
131929–131952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1989
TAK, VINYL PATIENT EXAMINATION GLOVES
K891645 · LYZ
Tak Ent., Inc.
General Hospital · 39d
Cleared Apr 25, 1989
TOPLAS VINYL PATIENT EXAMINATION GLOVE
K891646 · LYZ
Toplas Industrial Co., Ltd.
General Hospital · 39d
Cleared Apr 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891704 · LYY
Executive Commodities Exchange Co.
General Hospital · 36d
Cleared Apr 25, 1989
PHASER (SINGLE LINEAR MECHANICAL MASSAGE)
K891871 · ISA
Monad Corp.
Physical Medicine · 29d
Cleared Apr 25, 1989
FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE
K892000 · FAM
Schott Fiber Optics, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 25, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892096 · LYY
Grand Universe Trading Co., Ltd.
General Hospital · 22d
Cleared Apr 25, 1989
PROTEX PATIENT EXAMINATION GLOVES (LATEX)
K892115 · LYY
Pt Nusa Dipa Perdana
General Hospital · 21d
Cleared Apr 25, 1989
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
K892262 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 20d
Cleared Apr 24, 1989
LEUNOMED RFB 5000
K881164 · HCC
Hemodynamics, Inc.
Neurology · 402d
Cleared Apr 24, 1989
REBUILDER BUCKET SYSTEM
K882980 · GZJ
Micromed, Inc.
Neurology · 283d
Cleared Apr 24, 1989
CL UNIVERSAL HIP DEVICE
K885146 · KWI
Lima Intl. Corp.
Orthopedic · 130d
Cleared Apr 24, 1989
USCI 7F GUIDE CATHETER
K890420 · DQO
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Apr 24, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891267 · LYY
Genie Rubber Products Co.
General Hospital · 45d
Cleared Apr 24, 1989
MOBILIMB CPM SHOULDER UNIT
K891345 · BXB
Toronto Medical Corp.
Physical Medicine · 46d
Cleared Apr 24, 1989
SUCTION CONTROL VALVE
K892343 · BSY
Concord/Portex
Anesthesiology · 19d
Cleared Apr 21, 1989
COOK-GIANTURCO BILIARY Z STENT
K882610 · FGE
Cook, Inc.
Gastroenterology & Urology · 301d
Cleared Apr 21, 1989
MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER
K883948 · DYG
NuMED, Inc.
Cardiovascular · 220d
Cleared Apr 21, 1989
IMAGER FLUSH CATHETERS
K884354 · DQO
Medi-Tech, Inc.
Cardiovascular · 186d
Cleared Apr 21, 1989
BERICHROM ALPHA-2-ANTIPLASMIN
K884797 · GGP
Behring Diagnostics, Inc.
Hematology · 156d
Cleared Apr 21, 1989
RETRACTABLE PISTON SYRINGE W/LUER-LOCK COLLAR
K884841 · FMF
Hall Medical Laboratories
General Hospital · 151d
Cleared Apr 21, 1989
KAMED STETHOSCOPE
K890126 · LDE
D.R.G.
Cardiovascular · 99d
Cleared Apr 21, 1989
FTK FECAL TRANSPORT KIT
K890134 · LIO
Evergreen Scientific, Inc.
Microbiology · 98d
Cleared Apr 21, 1989
GOLDEN MEAN MACHINE(TM) (CLASS 2)
K890401 · ISD
Bennett Ergonomic Labs, Inc.
Physical Medicine · 87d
Cleared Apr 21, 1989
SIGMOID TONOMITOR
K890466 · GBT
Tonometrics, Inc.
Gastroenterology & Urology · 80d