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
144097–144120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1986
ETP 180 CARDIAC PACEMAKER (EXTERNAL)
K860551 · DRO
Biotronics Corp.
Cardiovascular · 76d
Cleared Apr 30, 1986
HEARTSTART 2000
K860676 · MKJ
First Medical Devices Corp.
Cardiovascular · 64d
Cleared Apr 30, 1986
FACEGLOV,ANESTHETIC GAS MASK
K860686 · BSJ
Loran , Ltd.
Anesthesiology · 64d
Cleared Apr 30, 1986
ZEISS VOICE CONTROL SYSTEM FOR OPMI'S
K860811 · EPT
Carl Zeiss, Inc.
General & Plastic Surgery · 57d
Cleared Apr 30, 1986
OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH
K861083 · LYC
Coors Biomedical Co.
Dental · 40d
Cleared Apr 30, 1986
OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH
K861084 · LYC
Coors Biomedical Co.
Dental · 40d
Cleared Apr 30, 1986
BISCO'S PORCELAIN VENEER SYSTEM
K861148 · EBF
Bisco, Inc.
Dental · 35d
Cleared Apr 30, 1986
STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
K861196 · KKX
Deroyal Industries, Inc.
General Hospital · 30d
Cleared Apr 30, 1986
DIALET LANCING DEVICE
K861265 · FMK
Home Diagnostics, Inc.
General & Plastic Surgery · 26d
Cleared Apr 30, 1986
ISOTRAK AMYLASE ISOENZYME CONTROL SET
K861329 · JJT
Behring Diagnostics, Inc.
Chemistry · 21d
Cleared Apr 29, 1986
LEE ELECTRONICS PAL
K854637 · ESD
Lee Electronics
Ear, Nose, Throat · 161d
Cleared Apr 29, 1986
BARD PARKER PERFUSION CATHETER
K855201 · DQY
Bd Becton Dickinson Vacutainer...
Cardiovascular · 123d
Cleared Apr 29, 1986
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362 · KNX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 89d
Cleared Apr 29, 1986
CARDIO-COOL
K860523 · DTR
Bio-Vascular, Inc.
Cardiovascular · 76d
Cleared Apr 29, 1986
SARNS OXYGENATOR SYSTEM
K860539 · DTZ
3M Health Care, Sarns
Cardiovascular · 76d
Cleared Apr 29, 1986
SPACELABS MEDICAL WORKSTATION
K860834 · DSI
Spacelabs, Inc.
Cardiovascular · 55d
Cleared Apr 29, 1986
SUBCLAVIAN INTRODUCER SET
K860898 · DYB
Infusaid Corp.
Cardiovascular · 50d
Cleared Apr 29, 1986
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
K860984 · CEP
Hybritech, Inc.
Chemistry · 43d
Cleared Apr 29, 1986
PERCUTANEOUS CATHETERS
K861008 · DQY
Micor, Inc.
Cardiovascular · 42d
Cleared Apr 29, 1986
MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER
K861176 · DTB
Intermedics, Inc.
Cardiovascular · 29d
Cleared Apr 29, 1986
NEONATAL UNILET
K861243 · FMK
Ulster Scientific, Inc.
General & Plastic Surgery · 27d
Cleared Apr 28, 1986
CHLAMYSET ANTIGEN
K853401 · LJP
Orion Corp.
Microbiology · 259d
Cleared Apr 28, 1986
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
K854370 · DXN
Nihon Kohden America, Inc.
Cardiovascular · 181d
Cleared Apr 28, 1986
PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3
K860287 · DXN
Healthcheck Corp.
Cardiovascular · 90d