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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
139129–139152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1987
BIOFILM TRANS. POUCH ULCER & WOUND DRESSING
K872101 · NAD
The Bfgoodrich Co.
General & Plastic Surgery · 29d
Cleared Jun 30, 1987
XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.
K872168 · LXB
Xomed, Inc.
Ear, Nose, Throat · 22d
Cleared Jun 30, 1987
SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER
K872225 · KOT
Block Drug Company, Inc.
Dental · 21d
Cleared Jun 29, 1987
ROBINJECT
K864984 · KZE
International Medical Products, Inc.
General Hospital · 189d
Cleared Jun 29, 1987
MODIFIED SALTEX REAGENT STRIPS
K870214 · CHK
Miles Laboratories, Inc.
Chemistry · 160d
Cleared Jun 29, 1987
NIGHTWATCH(TM) SYSTEM
K870578 · DSH
Buckman Co., Inc.
Cardiovascular · 139d
Cleared Jun 29, 1987
DORCHES(TM) LIFESOUND(TM)
K870810 · DQD
Centauri Manufacturing, Inc.
Cardiovascular · 118d
Cleared Jun 29, 1987
ULTIMATE PROTECTIVE SAFETY CAP (UPS CAP)
K871142 · FMI
Peachtree Medical, Inc.
General Hospital · 98d
Cleared Jun 29, 1987
LES RAD FILTER
K871227 · ITY
M. D. Products
Radiology · 94d
Cleared Jun 29, 1987
KINESTIM MUSCLE STIMULATOR
K871472 · IPF
Promatek Industries, Ltd.
Physical Medicine · 76d
Cleared Jun 29, 1987
STIMULATOR, ULTRASOUND AND MUSCLE
K871647 · IMG
Amy West
Physical Medicine · 62d
Cleared Jun 29, 1987
MECONIUM SUCTION CATHETER
K871825 · BSY
Concord Laboratories, Inc.
Anesthesiology · 49d
Cleared Jun 29, 1987
PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE
K871826 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 49d
Cleared Jun 29, 1987
LECTEC NON-INVASIVE PACING ELECTRODE
K872012 · DRO
Lectec Corp.
Cardiovascular · 34d
Cleared Jun 29, 1987
VENTRESCREEN (TM) MONO
K872032 · KTN
Ventrex Laboratories, Inc.
Immunology · 33d
Cleared Jun 26, 1987
ENTERAL ADMINISTRATION SET
K870623 · FPD
Plasco, Inc.
Gastroenterology & Urology · 134d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2
K871228 · GQS
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL
K871229 · GOD
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS
K871230 · LKT
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B
K871231 · GNX
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3
K871232 · GQS
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A
K871233 · GNX
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1
K871234 · GQS
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ORTHO* SPECIMEN COLLECTION CYTOBRUSH
K871552 · HHT
Ortho Diagnostic Systems, Inc.
Obstetrics & Gynecology · 65d