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.

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

Filters: Cleared only ×
175,230 results
42097–42120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 2012
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
K123080 · JXM
Chemtron Biotech, Inc.
Toxicology · 59d
Cleared Nov 29, 2012
PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM
K123207 · MAX
Osteomed LP
Orthopedic · 48d
Cleared Nov 28, 2012
TXCELL SCANNING LASER DELIVERY SYSTEM
K121475 · GEX
Iridex Corp
General & Plastic Surgery · 194d
Cleared Nov 28, 2012
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
K121775 · LGZ
Vital Signs, Inc., A GE Healthcare...
General Hospital · 163d
Cleared Nov 28, 2012
MINIFIX BALL MINIFIX ONE
K122052 · DZE
Bonafix Surgical and Dental Implants,...
Dental · 139d
Cleared Nov 28, 2012
SJM CONFIRM
K122161 · MXC
St Jude Medical
Cardiovascular · 131d
Cleared Nov 28, 2012
CHECKMATE SMALL BONE FUSION SYSTEM
K122334 · HRS
Arthrosurface, Inc.
Orthopedic · 118d
Cleared Nov 28, 2012
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL...
K122420 · MRG
Diazyme Laboratories
Chemistry · 111d
Cleared Nov 28, 2012
VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
K122429 · LLZ
Object Research Systems (Ors), Inc.
Radiology · 111d
Cleared Nov 28, 2012
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
K122495 · MQB
Perkinelmer, Inc.
Radiology · 104d
Cleared Nov 28, 2012
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL...
K122543 · KRD
MicroVention, Inc.
Cardiovascular · 99d
Cleared Nov 28, 2012
BLIP MODEL BP-700WF
K123020 · DXN
Carematix, Inc.
Cardiovascular · 61d
Cleared Nov 28, 2012
SEAL ONE
K123035 · DXC
Perouse Medical
Cardiovascular · 61d
Cleared Nov 28, 2012
CERARESIN BOND
K123119 · KLE
Shofu Dental Corporation
Dental · 56d
Cleared Nov 28, 2012
ILLICO FS FACET FIXATION SYSTEM
K123218 · MRW
Alphatec Spine, Inc.
Orthopedic · 44d
Cleared Nov 28, 2012
AZUR CX DETACHABLE 18
K123384 · KRD
MicroVention, Inc.
Cardiovascular · 26d
Cleared Nov 27, 2012
STABILIZ FIXATION SYSTEM
K120651 · HRS
Stabiliz Orthopaedics, LLC
Orthopedic · 270d
Cleared Nov 27, 2012
MERETE LOCKING BONE PLATE SYSTEM III
K120787 · HRS
Merete Medical GmbH
Orthopedic · 257d
Cleared Nov 27, 2012
WATER BOTTLE CAP IRRIGATON SYSTEM
K120862 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 250d
Cleared Nov 27, 2012
D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000
K121093 · EBZ
Dxm Co., Ltd.
Dental · 231d
Cleared Nov 27, 2012
PICOSURE WORKSTATION
K121346 · GEX
Cynosure, Inc.
General & Plastic Surgery · 207d
Cleared Nov 27, 2012
MULTICROSS SUPPORT CATHETER
K121763 · DQY
Roxwood Medical, Inc.
Cardiovascular · 165d
Cleared Nov 27, 2012
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE +...
K121989 · MQV
Exactech, Inc.
Orthopedic · 144d
Cleared Nov 27, 2012
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
K122561 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 97d