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
82801–82824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2000
SLENDAIR 4000 COMPRESSION SYSTEM
K994057 · IRP
Medical Compression Systems (Dbn) , Ltd.
Physical Medicine · 94d
Cleared Mar 03, 2000
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
K994125 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 87d
Cleared Mar 03, 2000
FIBRINOGEN CALIBRATOR KIT
K994341 · GFX
Dade Behring, Inc.
Hematology · 71d
Cleared Mar 03, 2000
KSEA SCB-RUI
K994348 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 71d
Cleared Mar 03, 2000
SOAKER CATHETER
K994374 · FRN
I-Flow Corp.
General Hospital · 67d
Cleared Mar 03, 2000
VENUSA, LTD. EXTENSION SET WITH FILTER
K994429 · FPA
Venusa , Ltd.
General Hospital · 64d
Cleared Mar 02, 2000
HARDYDISK TICARILLIN 75MCG
K000175 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Mar 02, 2000
HARDYDISK, CARBENICILLIN, 100MCG
K000181 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Mar 02, 2000
DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR
K000226 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 35d
Cleared Mar 02, 2000
TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
K000231 · JJX
Biosite Incorporated
Chemistry · 35d
Cleared Mar 02, 2000
BACT/ALERT MB CULTURE BOTTLE
K000378 · MDB
Organon Teknika Corp.
Microbiology · 24d
Cleared Mar 02, 2000
TERUMO NEEDLE WITH LOCKING SHEATH
K000387 · FMI
Terumo Medical Corp.
General Hospital · 24d
Cleared Mar 02, 2000
SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50...
K993117 · LYY
Safeskin Corp.
General Hospital · 164d
Cleared Mar 02, 2000
MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
K993170 · FYA
Medline Industries, Inc.
General Hospital · 162d
Cleared Mar 02, 2000
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
K993610 · LYC
Osteogenics Biomedical, Inc.
Dental · 129d
Cleared Mar 02, 2000
MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE
K993811 · LYY
Multisafe Sdn. Bhd.
General Hospital · 113d
Cleared Mar 02, 2000
UBAS
K993941 · KWX
Marukin Diagnostics
Chemistry · 104d
Cleared Mar 02, 2000
TOOTHBRUSH WASH
K994144 · EFW
Cal Huech, Inc.
Dental · 86d
Cleared Mar 02, 2000
HYLASHIELD CL
K994170 · MRC
Biomatrix, Inc.
Ophthalmic · 83d
Cleared Mar 02, 2000
PULPDENT CAVITY PREPARATION III
K994180 · LBH
Pulpdent Corp.
Dental · 83d
Cleared Mar 02, 2000
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
K994282 · LNH
Medis Medical Imaging Systems BV
Radiology · 73d
Cleared Mar 02, 2000
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
K994328 · FTL
Genzyme Corp.
General & Plastic Surgery · 71d
Cleared Mar 01, 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE
K000011 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 58d
Cleared Mar 01, 2000
MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
K000073 · GXI
Mercury Medical
Neurology · 51d