FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71665–71688 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2003
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
K024307 · IMI
Sybaritic, Inc.
Physical Medicine · 190d
Cleared Jul 02, 2003
MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE...
K030113 · DJG
Branan Medical Corp.
Toxicology · 170d
Cleared Jul 02, 2003
C-REACTIVE PROTEIN (CRP)
K030899 · DCN
Abbott Laboratories
Chemistry · 100d
Cleared Jul 02, 2003
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
K031276 · KWQ
Synthes (Usa)
Orthopedic · 71d
Cleared Jul 02, 2003
PERSONAL DIGITAL WORKSTATION (PDW)
K031372 · LLZ
Maxxvision, LLC
Radiology · 63d
Cleared Jul 02, 2003
OPTIBOND FL
K031444 · KLE
Kerr Dental Materials Center
Dental · 56d
Cleared Jul 02, 2003
FILL-IN
K031476 · EBG
Sybron Dental Specialties, Inc.
Dental · 54d
Cleared Jul 02, 2003
MICROHEATER
K031478 · BSB
Belmont Instrument Corp.
Hematology · 51d
Cleared Jul 02, 2003
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
K031688 · DTL
Guidant Corporation
Cardiovascular · 30d
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