FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
75361–75384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2002
MID LABS AUTONOMOUS VIT ENHANCER (AVE)
K020911 · HQE
Medical Instrument Development...
Ophthalmic · 40d
Cleared Apr 29, 2002
BUSSE UMBILICAL CORD CLAMP CUTTER
K021055 · HFW
Busse Hospital Disposables, Inc.
Obstetrics & Gynecology · 28d
Cleared Apr 29, 2002
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
K021155 · JJW
Medical Analysis Systems, Inc.
Chemistry · 19d
Cleared Apr 26, 2002
CRYOPEN AND ACCESSORIES
K012214 · GEH
Cimex Biotech, LLC
General & Plastic Surgery · 284d
Cleared Apr 26, 2002
MICROJET CRONO
K013234 · FRN
Cane S.R.L.
General Hospital · 211d
Cleared Apr 26, 2002
MICROJET MODEL # CD4 AND CD4/20
K013776 · FRN
Cane S.R.I.
General Hospital · 164d
Cleared Apr 26, 2002
MALE LATEX CONDOM WITH RIBBED SURFACE
K020272 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 88d
Cleared Apr 26, 2002
LAP DISC 120 X 120MM X 2CM #LD111
K020307 · GCJ
Hakko Shoji Co., Ltd.
General & Plastic Surgery · 87d
Cleared Apr 26, 2002
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
K020392 · LPL
CooperVision, Inc.
Ophthalmic · 79d
Cleared Apr 26, 2002
FUSION 7D
K020546 · LLZ
Mirada Solutions , Ltd.
Radiology · 66d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
K020556 · JWY
Dade Microscan, Inc.
Microbiology · 65d
Cleared Apr 26, 2002
GC FUJI ORTHO BAND PASTE PAK
K020578 · DYH
GC America, Inc.
Dental · 64d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
K020626 · LTT
Dade Microscan, Inc.
Microbiology · 59d
Cleared Apr 26, 2002
OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS
K020690 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 53d
Cleared Apr 26, 2002
SIIS#1 TISSUE SUSPENSION SYSTEM
K020705 · OTN
Tag Medical Products
Gastroenterology & Urology · 53d
Cleared Apr 26, 2002
SERRALSILK
K020901 · GAP
Serral, S.A. DE C.V.
General & Plastic Surgery · 37d
Cleared Apr 26, 2002
SUPER EON PLUS FEMORAL STEMS
K020989 · JDI
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Apr 26, 2002
ACIST PLUS 4 ANGIOGRAPHIC CATHETER
K021015 · DQO
Acist Medical Systems
Cardiovascular · 28d
Cleared Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
K021123 · MDB
bioMerieux, Inc.
Microbiology · 18d
Cleared Apr 26, 2002
SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
K021197 · FMF
Hosuk Co., Ltd.
General Hospital · 10d
Cleared Apr 25, 2002
COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
K010128 · DYB
Cook Vascular, Inc.
Cardiovascular · 464d
Cleared Apr 25, 2002
PVS BASIC 2
K013310 · HQD
Paragon Vision Sciences
Ophthalmic · 203d
Cleared Apr 25, 2002
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
K013517 · DQY
Medtronic Vascular
Cardiovascular · 185d
Cleared Apr 25, 2002
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
K014089 · DIS
Sun Biomedical Laboratories, Inc.
Toxicology · 135d