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
130393–130416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1989
THE PUDENZ IN LINE VALVE
K894072 · JXG
Baxter Healthcare Corp
Neurology · 60d
Cleared Aug 07, 1989
NIDEK MODEL AKC-8000
K894273 · HQF
Nidek, Inc.
Ophthalmic · 46d
Cleared Aug 07, 1989
OXYGEN THERAPY REGULATOR
K894302 · CAN
Modern Engineering Co., Inc.
Anesthesiology · 96d
Cleared Aug 07, 1989
SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER
K894396 · GEX
Surgilase, Inc.
General & Plastic Surgery · 21d
Cleared Aug 07, 1989
LIGHTSCOPE SET
K894557 · HRW
Optik
Neurology · 18d
Cleared Aug 07, 1989
MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET
K894558 · HRX
Optik
Orthopedic · 18d
Cleared Aug 04, 1989
PROWESS 2000
K884261 · KPQ
Small Systems Group, Inc.
Radiology · 297d
Cleared Aug 04, 1989
TRT (ACUSON) NEEDLE GUIDE KIT, STERILE
K892068 · FCG
Amedic USA
Gastroenterology & Urology · 127d
Cleared Aug 04, 1989
QUICKPAD (ALCOHOL SWABS)
K892193 · LKB
Holtsch Co., Inc.
General Hospital · 121d
Cleared Aug 04, 1989
NON-STERILE PATIENT EXAMINATION GLOVES
K892772 · LYY
Care-Pro Industries, Inc.
General Hospital · 113d
Cleared Aug 04, 1989
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K893043 · CBK
Puritan Bennett Corp.
Anesthesiology · 102d
Cleared Aug 04, 1989
EASY BREATHER MODEL 100
K893213 · BYT
Progressive Productions , Ltd.
Anesthesiology · 99d
Cleared Aug 04, 1989
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
K893432 · ESD
Electone, Inc.
Ear, Nose, Throat · 94d
Cleared Aug 04, 1989
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
K893508 · JFH
Baxter Healthcare Corp
Pathology · 91d
Cleared Aug 04, 1989
PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT
K893725 · HEB
Playtex Family Products, Inc.
Obstetrics & Gynecology · 79d
Cleared Aug 04, 1989
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
K893927 · ESD
Resound Corp.
Ear, Nose, Throat · 65d
Cleared Aug 04, 1989
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031 · HIO
Baxter Healthcare Corp
Obstetrics & Gynecology · 59d
Cleared Aug 04, 1989
SURGICAL DYNAMICS DISCOGRAPHY SYSTEM
K894336
Surgical Dynamics, Inc.
General & Plastic Surgery · 21d
Cleared Aug 04, 1989
QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
K894538 · DBN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 15d
Cleared Aug 03, 1989
BURRON TEFLON-COATED GUIDEWIRE
K884183 · DQX
Burron Medical, Inc.
Cardiovascular · 303d
Cleared Aug 03, 1989
JAMES SURGICAL SYSTEM J1000
K890195 · HQE
O.R. Specialties, Inc.
Ophthalmic · 197d
Cleared Aug 03, 1989
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)
K890402 · FAE
Mentor Corp.
Gastroenterology & Urology · 191d
Cleared Aug 03, 1989
AMBULATORY INFUSION PUMP
K890862 · FRN
Medfusion, Inc.
General Hospital · 163d
Cleared Aug 03, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891184 · LYY
Healthcare Gloves Sdn Bhd
General Hospital · 150d