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
88057–88080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1998
SEARE BIOMEDICAL SILICONE SHEETING
K983041 · MIB
Seare Biomedical Corp.
General & Plastic Surgery · 30d
Cleared Sep 30, 1998
SEARE BIOMEDICAL SILICONE BLOCK
K983043 · MIC
Seare Biomedical Corp.
General & Plastic Surgery · 30d
Cleared Sep 30, 1998
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4...
K983161 · ELR
Sabre-K , Ltd.
Dental · 21d
Cleared Sep 29, 1998
COMBISON 530D WITH POWER DOPPLER MODE
K974813 · IYN
Medison America, Inc.
Radiology · 280d
Cleared Sep 29, 1998
HYBRID CAPTURE SYSTEM CMV DNA ASSAY
K974901 · LJO
Digene Corp.
Microbiology · 272d
Cleared Sep 29, 1998
XKNIFE-4
K981055 · IYE
Radionics, Inc.
Radiology · 190d
Cleared Sep 29, 1998
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
K981306 · LGC
Diamedix Corp.
Microbiology · 172d
Cleared Sep 29, 1998
AUTOMATED MEDICAL REPORT WRITER
K981553 · KPS
Woodson and Associates, LLC
Radiology · 151d
Cleared Sep 29, 1998
PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM
K981834 · IYN
Perception, Inc.
Radiology · 126d
Cleared Sep 29, 1998
DYNAMIC SHIELDING RADIATION TABLE
K982446 · JAI
American Biophysics, Inc.
Radiology · 76d
Cleared Sep 29, 1998
LSVP INTERNATIONAL BIOPSY FORCEPS
K982983 · EOQ
Lsvp Intl., Inc.
Ear, Nose, Throat · 34d
Cleared Sep 29, 1998
PHILIPS OMNIDIAGNOST
K982993 · OWB
Philips Medical Systems, Inc.
Radiology · 33d
Cleared Sep 29, 1998
LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
K983130 · JJY
Kamiya Biomedical Co.
Immunology · 21d
Cleared Sep 29, 1998
ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
K983241 · JJY
Kamiya Biomedical Co.
Immunology · 14d
Cleared Sep 28, 1998
PGK DEVICE (MODIFIED)
K980997 · IWJ
Pgk, Inc.
Radiology · 195d
Cleared Sep 28, 1998
IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA...
K981226 · GQP
Dako Diagnostics , Ltd.
Microbiology · 188d
Cleared Sep 28, 1998
BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720
K981394 · DXH
Braemar Corp.
General Hospital · 164d
Cleared Sep 28, 1998
COAMATIC PLASMIN INHIBITOR
K981817 · GGP
Instrumentation Laboratory CO
Hematology · 129d
Cleared Sep 28, 1998
IS-VZU IGG TEST SYSTEM
K981867 · LFY
Diamedix Corp.
Microbiology · 123d
Cleared Sep 28, 1998
COBAS INTEGRA REAGENT CASSETTES
K982382 · CFN
Roche Diagnostic Systems, Inc.
Immunology · 82d
Cleared Sep 28, 1998
AST
K983131 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Sep 28, 1998
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN...
K983147 · DKE
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Sep 25, 1998
BLUNT SYRINGE CANNULA
K971924 · FMI
B.Braun Medical, Inc.
General Hospital · 490d
Cleared Sep 25, 1998
PRESS-MATE ADVANTAGE
K973637 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 366d