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

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176,076 results
155089–155112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1984
SURG-A-STAT FINE TIP
K840374
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery
Cleared Jan 27, 1984
ADJUST-A-TEMP EXTRA FINE TIP
K840378
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery
Cleared Jan 26, 1984
RAYDEN MEDICAL MINI PULSE VOLUME RECORD
K833155 · DSB
Burditt & Calkins-Siemens-Elema
Cardiovascular · 133d
Cleared Jan 26, 1984
AMBULASE XAM-15 XANAR SURG. LASER
K833325
Xanar, Inc.
General & Plastic Surgery · 121d
Cleared Jan 26, 1984
ROTARY VASCULAR KNIFE
K833547 · DWS
Formedco, Inc.
Cardiovascular · 106d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE BARBITURATE
K833577 · DIS
Syva Co.
Toxicology · 106d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE BENZODIAZEPINE
K833578 · JXM
Syva Co.
Toxicology · 106d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE AMPHETAMINE
K833579 · DKZ
Syva Co.
Toxicology · 106d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE CANNABINOID
K833580 · LDJ
Syva Co.
Toxicology · 106d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE OPIATE ASSAY
K833581 · DJG
Syva Co.
Toxicology · 106d
Cleared Jan 26, 1984
P.T.I. DRESSING CHANGE TRAYS
K833758 · FMC
Packaging Technologies, Inc.
General Hospital · 92d
Cleared Jan 25, 1984
PMT-OPTICA LINE
K831118 · KDC
Pmt, Inc.
General & Plastic Surgery · 295d
Cleared Jan 25, 1984
SELECTRODE SYSTEM
K832634 · BWK
Bio-Stimu Trend Corp.
Neurology · 174d
Cleared Jan 25, 1984
BURLINGTON STERILE ANTIMICROBIAL STOCK
K833121 · KKX
Balfour, Inc.
General Hospital · 134d
Cleared Jan 25, 1984
BURLINGTON ANTIMICROBIAL STOCKINEETTE
K833122 · KKX
Balfour, Inc.
General Hospital · 134d
Cleared Jan 25, 1984
SKIN TECH. SURGI-STRIPS
K833258 · FPX
Lee Tec Corp.
General & Plastic Surgery · 127d
Cleared Jan 25, 1984
ACCURATE MEASUREMENT DEVICE KG-AMD
K833674 · GCX
Sorensen Research
General Hospital · 99d
Cleared Jan 25, 1984
AMER. V. MUELLER SURG. STAPLES ILA
K833698 · GDW
American Heyer Schulte
General & Plastic Surgery · 71d
Cleared Jan 25, 1984
PREPACELL THIN NEEDLE ASPIRATION TRAY
K833719 · KOD
Applied Medical Devices, Inc.
Gastroenterology & Urology · 93d
Cleared Jan 25, 1984
SINGLE-USE SURGICAL DRAPES
K833877 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 78d
Cleared Jan 25, 1984
STERILE SOLUTION WARMER
K833944 · LHC
National Fabtronix, Inc.
General Hospital · 71d
Cleared Jan 25, 1984
PUMP INFUSION WEARABLE INFUSION PUMP
K833966 · JSJ
Oximetrix, Inc.
Microbiology · 70d
Cleared Jan 25, 1984
LYMPHANGIOGRAPHY SET SPECIAL 30G
K834071 · FPA
Hyperion, Inc.
General Hospital · 61d
Cleared Jan 25, 1984
FLO-GARD 8000 COMPUTER CONTROL INFUSI
K834154 · LDR
Travenol Laboratories, S.A.
General Hospital · 54d