FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83305–83328 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2000
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
K000012 · DLZ
Diagnostic Products Corp.
Toxicology · 60d
Cleared Mar 03, 2000
CELL-CHEX
K000076 · GJR
Streck Laboratories, Inc.
Hematology · 53d
Cleared Mar 03, 2000
CORTEK CYSTOSCOPE
K000197 · FAJ
Cortek Endoscopy, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 03, 2000
CORTEK URETHEROSCOPE
K000200 · FGB
Cortek Endoscopy, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 03, 2000
PROTEGE WHEELCHAIR
K000602 · IOR
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 9d
Cleared Mar 03, 2000
IO-DRIVE
K993081 · EGJ
Selectivemed Components, Inc.
Physical Medicine · 170d
Cleared Mar 03, 2000
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
K993557 · DHR
Cogent Diagnotics , Ltd.
Immunology · 135d
Cleared Mar 03, 2000
ENDOSCOPIC ANTI FOG DEVICE
K993604 · OCT
Mectra Labs, Inc.
Gastroenterology & Urology · 130d
Cleared Mar 03, 2000
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957 · MYA
Dako Corp.
Pathology · 102d
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