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
83953–83976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1999
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
K990927 · CBF
Perry Baromedical Corp.
Anesthesiology · 238d
Cleared Nov 12, 1999
MICROALBUSTIX REAGENT STRIPS (OTC)
K991315 · JIR
Bayer Corp.
Chemistry · 207d
Cleared Nov 12, 1999
QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3
K992770 · JJY
Seracare Technology
Immunology · 87d
Cleared Nov 12, 1999
CONSTELLATION CATHETERS, MODEL 8039
K992777 · MTD
Boston Scientific Corp
Cardiovascular · 86d
Cleared Nov 12, 1999
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
K992790 · JZO
Brahms Diagnostica, LLC
Immunology · 85d
Cleared Nov 12, 1999
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
K992791 · JZO
Brahms Diagnostica, LLC
Immunology · 85d
Cleared Nov 12, 1999
LEAD STYLET,MODELS 6505,6506,6507,6508
K992863 · DRB
Guidant Corp.
Cardiovascular · 79d
Cleared Nov 12, 1999
PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
K992921 · LCP
Primus Corp.
Hematology · 74d
Cleared Nov 12, 1999
AUTOSTAT II ANTI-GLIADIN IGA ELISA
K993086 · MST
Cogent Diagnotics , Ltd.
Immunology · 58d
Cleared Nov 12, 1999
AUTOSTAT II ANTI-GLIADIN IGG ELISA
K993087 · MST
Cogent Diagnotics , Ltd.
Immunology · 58d
Cleared Nov 12, 1999
VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96
K993108 · LJM
Pharmacia & Upjohn Co.
Immunology · 56d
Cleared Nov 12, 1999
VARELISA RECOMBI ANA PROFILE
K993109 · LJM
Pharmacia & Upjohn Co.
Immunology · 56d
Cleared Nov 12, 1999
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
K993162 · DDG
Wako Chemicals USA, Inc.
Immunology · 51d
Cleared Nov 12, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
K993250 · MST
Zeus Scientific, Inc.
Immunology · 45d
Cleared Nov 12, 1999
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
K993254 · CGN
Diagnostic Products Corp.
Chemistry · 45d
Cleared Nov 12, 1999
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · GGM
R&D Systems, Inc.
Hematology · 39d
Cleared Nov 12, 1999
EZFLOW MAX, MODEL 1007
K993558 · CAF
Piper Medical Products
Anesthesiology · 23d
Cleared Nov 12, 1999
IMPRESARIO
K993620 · DQK
Del Mar Medical Systems, LLC
Cardiovascular · 17d
Cleared Nov 12, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K993632 · CGA
Selfcare, Inc.
Immunology · 16d
Cleared Nov 12, 1999
LEGEND CRF FLUORO AND RAD SYSTEM
K993665 · KPR
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Nov 10, 1999
FS 1000 KNEE SYSTEM
K991052 · JWH
Renaissance Instruments, LLC
Orthopedic · 225d
Cleared Nov 10, 1999
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
K991320 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 205d
Cleared Nov 10, 1999
ROADRUNNER, PEP THERAPY DEVICE
K991561 · BWF
Dhd Healthcare Corp.
Anesthesiology · 190d
Cleared Nov 10, 1999
THE TAPER-FIT TOTAL HIP SYSTEM
K992234 · JDG
Corin USA
Orthopedic · 131d