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
84457–84480 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1999
MODIFIED BMP TROCHANTERIC PLATES
K993510 · HRS
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 16, 1999
HOWMEDICA OSTEONICS FEMORAL HEADS
K993601 · LWJ
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 16, 1999
SPECTRUM LIBRE WHEELCHAIR
K993640 · IOR
Freedom Designs, Inc.
Physical Medicine · 19d
Cleared Nov 16, 1999
UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND...
K993647 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 18d
Cleared Nov 16, 1999
MODIFIED LONG LENGTH GAMMA NAIL
K993670 · HSB
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Nov 16, 1999
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
K993715 · JJT
Seracare Technology
Immunology · 13d
Cleared Nov 15, 1999
ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC...
K992838 · KLE
Biomat Sciences, Inc.
Dental · 84d
Cleared Nov 15, 1999
MINIMED COM-STATION, HARDWARE-7301
K993012 · LZG
Medtronic Minimed
General Hospital · 68d
Cleared Nov 15, 1999
P10 SPECIAL
K993344 · EJH
North American Alloys, Inc.
Dental · 41d
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