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
79993–80016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · KWQ
Aesculap, Inc.
Orthopedic · 239d
Cleared May 08, 2001
SURGICAL TITANIUM MESH SYSTEM
K003043 · MQP
Depuyacromed
Orthopedic · 221d
Cleared May 08, 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · MNI
Blackstone Medical, Inc.
Orthopedic · 155d
Cleared May 08, 2001
CLARIS PLATE SYSTEM
K010369 · MNH
Ortho Tec, LLC
Orthopedic · 90d
Cleared May 08, 2001
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
K010472 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 77d
Cleared May 08, 2001
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
K010479 · HTY
Bonutti Research, Inc.
Orthopedic · 77d
Cleared May 08, 2001
SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
K010542 · HAW
Surgical Navigation Specialists, Inc.
Neurology · 74d
Cleared May 08, 2001
DJ ORTHOPEDICS INTERFERENCE SCREW
K010595 · HWC
Dj Orthopedics, LLC
Orthopedic · 69d
Cleared May 08, 2001
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
K010691 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 61d
Cleared May 08, 2001
RANDOX MYOGLOBIN
K010700 · DDR
Randox Laboratories, Ltd.
Chemistry · 61d
Cleared May 08, 2001
MEDLINE STERISET STERILIZATION CONTAINER
K010825 · FRG
Medline
General Hospital · 50d
Cleared May 08, 2001
OMNILINK .018 BILIARY STENT SYSTEM
K011039 · FGE
Guidant Corp.
Gastroenterology & Urology · 33d
Cleared May 08, 2001
QUICKVUE DIPSTICK STREP A
K011097 · GTY
Quidel Corp.
Microbiology · 27d
Cleared May 08, 2001
GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES
K011120 · FPA
Nipro Diabetes Systems, Inc.
General Hospital · 26d
Cleared May 08, 2001
AQUARIUS WORKSTATION
K011142 · LLZ
Terarecon,Inc.
Radiology · 25d
Cleared May 08, 2001
NEUROFAX, MODELS EEG-1100A, EEG-9100A
K011204 · OLV
Nihon Kohden America, Inc.
Neurology · 19d
Cleared May 08, 2001
EXHALE RF PROBE
K011267 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 12d
Cleared May 08, 2001
POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED
K011271 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 12d
Cleared May 07, 2001
ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
K003403 · JOS
Highland / Marietta, Inc.
General & Plastic Surgery · 187d
Cleared May 07, 2001
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS...
K003405 · KNF
Highland / Marietta, Inc.
Obstetrics & Gynecology · 187d
Cleared May 07, 2001
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
K010361 · GXR
Medtronic PS Medical
Neurology · 90d
Cleared May 07, 2001
D/C CORE MATERIAL
K010475 · EBF
Parkell, Inc.
Dental · 76d
Cleared May 07, 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520 · CGA
Instrumentation Laboratory CO
Chemistry · 74d
Cleared May 07, 2001
ACON STREP A RAPID TEST STRIP
K010582 · GTY
Acon Laboratories Co.
Microbiology · 69d