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
119881–119904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1991
CHOLINESTERASE LINEARITY CONTROL
K913496 · JJX
Creative Laboratory Products, Inc.
Chemistry · 36d
Cleared Sep 11, 1991
LATERALASE STERILE DISPOSABLE FIBER
K913513 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 35d
Cleared Sep 11, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIY
K913563 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 33d
Cleared Sep 11, 1991
AMYLASE REAGENT (PROCEDURE 577)
K913858 · JFJ
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Sep 10, 1991
EMG ACCESSORY FOR POSTUROGRAPHY
K901732 · IKN
Neurocom International, Inc.
Neurology · 511d
Cleared Sep 10, 1991
ANTI-GBM ANTIBODIES QUANTITATIVE KIT
K904181 · DBL
Biochemical Diagnostic, Inc.
Immunology · 364d
Cleared Sep 10, 1991
INFUSA PU SYRINGE INFUSION PUMP
K904924 · FRN
Ferguson Medical
General Hospital · 314d
Cleared Sep 10, 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
K905860 · JXG
Baxter Healthcare Corp
Neurology · 263d
Cleared Sep 10, 1991
CASIO BP-100
K910643 · DXN
Casio, Inc.
Cardiovascular · 209d
Cleared Sep 10, 1991
ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY
K910940 · JWH
Depuy, Inc.
Orthopedic · 188d
Cleared Sep 10, 1991
T-BOLT AND NUT
K911306 · HTN
Danek Medical, Inc.
Orthopedic · 169d
Cleared Sep 10, 1991
CODMAN DISPOSABLE SKULL PINS
K911723 · HBL
Codman & Shurtleff, Inc.
Neurology · 146d
Cleared Sep 10, 1991
VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER
K911759 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 145d
Cleared Sep 10, 1991
ACRA-CUT WIRE PASS DRILL
K911812 · HBE
Acra Cut, Inc.
Neurology · 139d
Cleared Sep 10, 1991
ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED
K911819 · HBE
Acra Cut, Inc.
Neurology · 139d
Cleared Sep 10, 1991
DSL BETA 2 MICROGLOBULIN (DSL 6200)
K911881 · JZG
Diagnostic Systems Laboratories, Inc.
Microbiology · 134d
Cleared Sep 10, 1991
SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF
K911959 · LNH
GE Medical Systems
Radiology · 130d
Cleared Sep 10, 1991
COX DISPOSABLE CYTOLOGY BRUSHES
K912407 · FDX
Cox Medical Ent., Inc.
Gastroenterology & Urology · 103d
Cleared Sep 10, 1991
SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER
K912494 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 97d
Cleared Sep 10, 1991
BARD(R) DISPOSABLE BIOPSY FORCEPS
K912549 · FCL
C.R. Bard, Inc.
Gastroenterology & Urology · 92d
Cleared Sep 10, 1991
MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM
K912627 · MHX
Ppg Industries, Inc.
Cardiovascular · 88d
Cleared Sep 10, 1991
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
K912679 · GJT
Baxter Healthcare Corp
Hematology · 84d
Cleared Sep 10, 1991
FIRST CHOICE(TM)
K912732 · CGA
Polymer Technology Corp.
Chemistry · 82d
Cleared Sep 10, 1991
12-PLY GAUZE PAD
K912951 · NAB
Cal West Trading Co.
General & Plastic Surgery · 70d