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
71161–71184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2003
LIFEVALVE CENTRAL VENOUS CATHTER
K031718 · LJS
Horizon Medical Products, Inc.
General Hospital · 29d
Cleared Jul 02, 2003
ESTHETIC ZIRCONIA ABUTMENT
K031719 · NHA
Nobel Biocare AB
Dental · 29d
Cleared Jul 02, 2003
SPI DENTAL IMPLANT ABUTMENTS
K031747 · NHA
Thommen Medical AG
Dental · 27d
Cleared Jul 02, 2003
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
K031790 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 22d
Cleared Jul 02, 2003
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
K031807 · DZL
Synthes (Usa)
Dental · 21d
Cleared Jul 02, 2003
ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX
K031827 · DWF
Medtronic Perfusion Systems
Cardiovascular · 19d
Cleared Jul 02, 2003
GE DELTA SOFTWARE OPTION FOR MRI
K031927 · LNH
GE Medical Systems
Radiology · 9d
Cleared Jul 01, 2003
JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK &...
K023668 · FPA
Jms North America Corp.
General Hospital · 243d
Cleared Jul 01, 2003
MACROPORE OS RECONSTRUCTION
K024169 · EZX
Macropore Biosurgery, Inc.
General & Plastic Surgery · 195d
Cleared Jul 01, 2003
GIVEN DIAGNOSTIC SYSTEM
K031033 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 91d
Cleared Jul 01, 2003
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
K031392 · DKC
Medical Analysis Systems, Inc.
Toxicology · 60d
Cleared Jul 01, 2003
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
K031441 · JJW
Medical Analysis Systems, Inc.
Chemistry · 56d
Cleared Jul 01, 2003
MAINLINE MAXIE HCG URINE PREGNANCY TEST
K031445 · JHI
Mainline Technology, Inc.
Chemistry · 55d
Cleared Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · HWC
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Jul 01, 2003
HL168R
K031695 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Jul 01, 2003
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
K031734 · JDI
Biomet, Inc.
Orthopedic · 27d
Cleared Jul 01, 2003
SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005
K031783 · FPA
Intravascular Incorporated
General Hospital · 21d
Cleared Jul 01, 2003
DEPUY CERAMIC FEMORAL HEADS
K031803 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Jul 01, 2003
HL888RA
K031835 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Jun 30, 2003
ANTIMICROBIAL ALGINATE DRESSING
K024298 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 188d
Cleared Jun 30, 2003
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
K024323 · MLO
Biomedical Systems Corp.
Cardiovascular · 186d
Cleared Jun 30, 2003
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
K030559 · ESW
Rusch Intl.
Gastroenterology & Urology · 129d
Cleared Jun 30, 2003
ASAP CYSTOSCOPE
K031141 · FAJ
Asap Endoscopic Products GmbH
Gastroenterology & Urology · 81d
Cleared Jun 30, 2003
MODIFICATION TO HERMES O.R. CONTROL CENTER
K031382 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 60d