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
128713–128736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 1989
OSBON PERSONAL LUBRICANT
K896207 · KMJ
Osbon Medical Systems, Ltd.
General Hospital · 36d
Cleared Dec 01, 1989
INJECTION PORT II --- FOR INTERMITTENT INJECTION
K896291 · FPA
The Medi-Dose Group
General Hospital · 31d
Cleared Dec 01, 1989
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
K896483 · DEB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 18d
Cleared Dec 01, 1989
ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
K896545 · GFO
Sigma Chemical Co.
Hematology · 14d
Cleared Nov 30, 1989
STERILE FOLEY CATHETER
K890310 · EYC
Kosan Far East Ent. , Ltd.
Gastroenterology & Urology · 311d
Cleared Nov 30, 1989
TON-SU'S VINYL EXAM GLOVES
K892584 · LYZ
Ton SU Co. , Ltd.
General Hospital · 232d
Cleared Nov 30, 1989
IFA SENSIBAC CEFACLOR
K892721 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 230d
Cleared Nov 30, 1989
SPACELABS MODEL 90900
K894093 · LOS
Spacelabs, Inc.
Cardiovascular · 174d
Cleared Nov 30, 1989
ANGEION HEMOSTASIS VALVE INTRODUCER
K894446 · DYB
Angeion Corp.
Cardiovascular · 136d
Cleared Nov 30, 1989
CARRINGTON DERMAL WOUND GEL
K894541 · FRO
Carrington Laboratories, Inc.
General & Plastic Surgery · 133d
Cleared Nov 30, 1989
16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE
K894878 · BSP
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE
K894879 · BSP
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL
K894880 · BSP
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
20GA X 7-1/2 THREADING BULLET POINT NEEDLE
K894881 · BSP
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
INFILTRATION PUMP SYRINGE
K894882 · BSP
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
SCD KNEE IMMOBILIZER
K895278 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 99d
Cleared Nov 30, 1989
COHERENT HOLMIUM:YAG SURGICAL LASER
K895518 · GEX
Lumenis, Inc.
General & Plastic Surgery · 79d
Cleared Nov 30, 1989
MAGNETOM M, H, 42, 63, 42 SP AND 63 SP
K895966 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 50d
Cleared Nov 30, 1989
DEVILBISS MODEL 6300D
K896090 · EPN
Devilbiss Health Care, Inc.
Ear, Nose, Throat · 42d
Cleared Nov 30, 1989
MODIFIED MODEL 535(TM) LUMINOMETER
K896117 · JJQ
Los Alamos Diagnostics
Chemistry · 41d
Cleared Nov 30, 1989
PORGES HOT BIOPSY FORCEPS
K896537 · KGE
Porges Corp.
Gastroenterology & Urology · 15d
Cleared Nov 29, 1989
APEXIT ROOT CANAL SEALER
K893794 · KIF
Williams Dental Co., Inc.
Dental · 191d
Cleared Nov 29, 1989
KRONAMAX KUBE
K893903 · KQX
Physicians Digital Co.
Neurology · 183d
Cleared Nov 29, 1989
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
K895103 · GTZ
Gen-Probe, Inc.
Microbiology · 106d