Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
72265–72288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2003
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS...
K031422 · DPS
Philips Medical Systems
Cardiovascular · 58d
Cleared Jul 03, 2003
STAND OUT
K031484 · ELW
Kerr Corp.
Dental · 52d
Cleared Jul 03, 2003
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K031623 · FZP
Coalescent Surgical
General & Plastic Surgery · 41d
Cleared Jul 03, 2003
ACCU-CHEK COMPACT TEST STRIP
K031755 · LFR
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Jul 03, 2003
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K031843 · NBW
Medline Industries, Inc.
Chemistry · 17d
Cleared Jul 02, 2003
READI-STRAND, MODEL PSSTRAND
K023179 · KXK
Worldwide Medical Technologies, LLC
Radiology · 281d
Cleared Jul 02, 2003
SECQUIRE CELL SEPARATOR
K024080 · JQC
Perfusion Partners & Assoc., Inc.
Hematology · 204d
Cleared Jul 02, 2003
S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
K024191 · BZD
Resmed, Ltd.
Anesthesiology · 194d
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