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
85729–85752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 1999
VECTORVISION2
K983831 · HAW
Brainlab AG
Neurology · 201d
Cleared May 19, 1999
OSTEOGRAM BONE DENSITOMETER
K984285 · KGI
Compumed, Inc.
Radiology · 169d
Cleared May 19, 1999
BIPAP HARMONY S/T, MODEL 1001445
K984407 · MNS
Respironics, Inc.
Anesthesiology · 161d
Cleared May 19, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
K990016 · JJY
Ortho-Clinical Diagnostics, Inc.
Immunology · 135d
Cleared May 19, 1999
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE...
K990522 · OLV
Lamont Medical, Inc.
Neurology · 90d
Cleared May 19, 1999
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
K990538 · HCC
Brainmaster
Neurology · 89d
Cleared May 19, 1999
VISTA STEREOSCOPE SYSTEM
K990635 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 82d
Cleared May 19, 1999
GALLINI ATRA-CUT NEEDLE
K990645 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 82d
Cleared May 19, 1999
EASTGATE PERSONAL MONITOR
K990731 · GCJ
Eastgate Trading Corp.
General & Plastic Surgery · 75d
Cleared May 19, 1999
ETB TROCAR SYSTEM
K990894 · GCJ
The Altomec Corp.
General & Plastic Surgery · 62d
Cleared May 19, 1999
ACP
K991010 · CKB
Abbott Diagnostics Mfg., Inc.
Chemistry · 54d
Cleared May 19, 1999
VACUTAINER BRAND CTAD TUBE (MULTIPLE)
K991120 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 47d
Cleared May 19, 1999
MODIFICATION OF N/T PROTEIN CONTROL SL
K991182 · JJY
Dade Behring, Inc.
Chemistry · 42d
Cleared May 19, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
K991364 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 29d
Cleared May 19, 1999
ELAN ALKALINE PHOSPHATE REAGENT KIT
K991387 · CJE
Elan Holdings, Inc.
Chemistry · 28d
Cleared May 19, 1999
DIAMOND II VALVE
K991429 · JXG
Phoenix Biomedical Corp.
Neurology · 23d
Cleared May 19, 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K991460 · MNH
Sofamor Danek
Orthopedic · 22d
Cleared May 19, 1999
NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
K991583 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 12d
Cleared May 18, 1999
LAMINOSS DENTAL IMPLANT
K982925 · DZE
Impladent , Ltd.
Dental · 271d
Cleared May 18, 1999
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
K984022 · MPB
Arrow Intl., Inc.
Gastroenterology & Urology · 187d
Cleared May 18, 1999
INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE
K990493 · GCJ
Innerdyne, Inc.
General & Plastic Surgery · 90d
Cleared May 18, 1999
OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
K990509 · EZL
Implemed, Inc.
Gastroenterology & Urology · 89d
Cleared May 18, 1999
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
K990672 · OKS
Hurricane Medical
Ophthalmic · 77d
Cleared May 18, 1999
THE VAULT
K990936 · FMI
Stik Stoppers, Inc.
General Hospital · 60d