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
128977–129000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1989
RHEUMELISA ASSAY FOR SM AUTOANTIBODIES
K895996 · LKP
Lipogen, Inc.
Immunology · 24d
Cleared Nov 06, 1989
RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES
K895997 · LKO
Lipogen, Inc.
Immunology · 24d
Cleared Nov 06, 1989
MODIFIED QM300 ALBUMIN ANTIBODY PACK
K896059 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Nov 03, 1989
MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES
K890665 · HRX
Dyonics, Inc.
Orthopedic · 267d
Cleared Nov 03, 1989
BIOFIX* BIODEGRADABLE FIXATION ROD
K890902 · HTY
Davis & Geck, Inc.
Orthopedic · 254d
Cleared Nov 03, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891256 · LYY
Raewiks, Inc.
General Hospital · 240d
Cleared Nov 03, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892167 · LYY
Raewiks, Inc.
General Hospital · 212d
Cleared Nov 03, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892561 · LYY
Maxicare Mfg. Corp.
General Hospital · 207d
Cleared Nov 03, 1989
TERM GUARD II DEVICE
K893770 · HFM
Tokos Medical Corp.
Obstetrics & Gynecology · 165d
Cleared Nov 03, 1989
LEVTECH SMALL BONE PLATE
K893928 · KTW
Buckman Co., Inc.
Orthopedic · 156d
Cleared Nov 03, 1989
SANISERV SURGICAL SLUSH SYSTEM
K894006 · JRM
Saniserv, Inc.
Physical Medicine · 151d
Cleared Nov 03, 1989
FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA
K894176 · ESD
Precision Hearing Instruments
Ear, Nose, Throat · 141d
Cleared Nov 03, 1989
PATIENT EXAMINATION GLOVES
K894352 · LYY
Rego Latex Progressive Corp.
General Hospital · 112d
Cleared Nov 03, 1989
MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM
K894958 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 88d
Cleared Nov 03, 1989
CMS VRB-1200
K895076 · DTN
Cobe Laboratories, Inc.
Cardiovascular · 81d
Cleared Nov 03, 1989
SURGICAL MASK/DENTAL MASK
K895077 · FXX
Ashton Medical Products, Inc.
General Hospital · 81d
Cleared Nov 03, 1989
ECHO GEL (RAINFOREST)
K895100 · ITX
Lead-Lok, Inc.
Radiology · 80d
Cleared Nov 03, 1989
NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS
K895226 · KWS
3M Company
Orthopedic · 81d
Cleared Nov 03, 1989
X-RAY DETECTABLE GAUZE SPONGE
K895372 · GDY
Keilei Intl., Inc.
General & Plastic Surgery · 66d
Cleared Nov 03, 1989
SAFE-T-CAP
K895432 · FMI
Ausmedics Pty , Ltd.
General Hospital · 56d
Cleared Nov 03, 1989
POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES
K895669 · KGO
Safeskin Corp.
General Hospital · 45d
Cleared Nov 03, 1989
KDR ACETABULAR COMPONENT
K895702 · LWJ
Osteonics Corp.
Orthopedic · 42d
Cleared Nov 03, 1989
BABY MAC ELECTROCARDIOGRAPH ELECTRODE
K895834 · DRX
Marquette Electronics, Inc.
Cardiovascular · 32d
Cleared Nov 03, 1989
PALESTRANT IRRIGATION AND DRAINAGE SET
K896087 · KGZ
North American Instrument Corp.
General & Plastic Surgery · 15d