Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
140017–140040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1987
ADENOLEX (R) LATEX AGGLUTINATION TEST
K864645 · GOD
Orion Diagnostica, Inc.
Microbiology · 191d
Cleared Jun 04, 1987
HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
K870814 · GQL
Microscan Div. Baxter Healthcare Corp.
Microbiology · 93d
Cleared Jun 04, 1987
KODNER ANAL PERIONEAL RETRACTOR
K870897 · FFO
Sur-Med Instruments, Inc.
Gastroenterology & Urology · 91d
Cleared Jun 04, 1987
IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP
K870991 · FRN
Imed Corp.
General Hospital · 85d
Cleared Jun 04, 1987
IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP
K870992 · FRN
Imed Corp.
General Hospital · 85d
Cleared Jun 04, 1987
ENTROSET-SW
K871003 · KNT
White River (Tm)
Gastroenterology & Urology · 84d
Cleared Jun 04, 1987
TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT
K871219 · DZE
Depuy, Inc.
Dental · 69d
Cleared Jun 04, 1987
FIRST AID KIT, VARIOUS SIZES
K871376 · LRR
Fraass Survival Systems, Inc.
General & Plastic Surgery · 58d
Cleared Jun 04, 1987
PROSTHETIC - FEMORAL HIP COMPONENT
K871462 · JDI
Louis A. Serafin, Jr., M.D.
Orthopedic · 51d
Cleared Jun 04, 1987
ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)
K871780 · CIT
Biochemical Trade, Inc.
Chemistry · 29d
Cleared Jun 03, 1987
BILIRUBIN TESTER
K870095 · CIG
Wako Chemicals USA, Inc.
Chemistry · 145d
Cleared Jun 03, 1987
FREEDOM SET II WITH TRIFLEX VALVE
K870626 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 110d
Cleared Jun 03, 1987
HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS
K870979 · KPO
Inventory Supply Corp.
Gastroenterology & Urology · 85d
Cleared Jun 03, 1987
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
K871235 · JHI
Hybritech, Inc.
Chemistry · 68d
Cleared Jun 03, 1987
KRONNER COLLES-FOREARM EXTERNAL FIXATION
K871248 · KTT
Kronner Medical
Orthopedic · 65d
Cleared Jun 03, 1987
ANALYZER: NOVA STAT PROFILE 3 ANALYZER
K871397 · CHL
Nova Biomedical Corp.
Chemistry · 57d
Cleared Jun 03, 1987
25MM PEYMAN WIDE FIELD YAG LASER LENS
K871450 · HJK
Ocular Instruments, Inc.
Ophthalmic · 51d
Cleared Jun 03, 1987
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
K871485 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 49d
Cleared Jun 03, 1987
VOROSCOPE(TM)
K871735 · HLJ
Australian Biomedical Corporation , Ltd.
Ophthalmic · 29d
Cleared Jun 03, 1987
KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY
K871772 · JWH
Howmedica Corp.
Orthopedic · 28d
Cleared Jun 03, 1987
ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
K871781 · CFJ
Biochemical Trade, Inc.
Chemistry · 28d
Cleared Jun 03, 1987
THE URIC ACID REAGENT SET
K871902 · KNK
Macomb Biotechnology, Inc.
Chemistry · 19d
Cleared Jun 03, 1987
T P C (TONOMETER PROBE COVER)
K871935 · HKX
Krb Ent.
Ophthalmic · 15d
Cleared Jun 03, 1987
D.A.T. (TM) AMYLASE REAGENT
K871943 · CIJ
Behring Diagnostics, Inc.
Chemistry · 15d