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
158305–158328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1983
HANDI-WASH
K823787 · LIB
Dynatech Corp.
Chemistry · 83d
Cleared Mar 09, 1983
COVER-ROLL STRETCH
K823879 · NAB
Beiersdorf, Inc.
General & Plastic Surgery · 72d
Cleared Mar 09, 1983
BACTIGEN-N. MENINGITIDIS
K823880 · GTJ
Armkel, LLC
Microbiology · 72d
Cleared Mar 09, 1983
TELEMETRY SYSTEM
K823906 · DRG
Transkinetic Systems, Inc.
Cardiovascular · 71d
Cleared Mar 09, 1983
ARTEC TWIST VALVE
K830056 · BTC
Artec Environmental Monitoring Division
Anesthesiology · 62d
Cleared Mar 09, 1983
ENDECO ACOUSTIC OTOSCOPE
K830139 · ETY
Endeco Medical, Inc.
Ear, Nose, Throat · 55d
Cleared Mar 09, 1983
PNEUMATIC ANTERIOR CHAMBER MAINTAINER
K830143
Diversatronics, Inc.
General & Plastic Surgery · 54d
Cleared Mar 09, 1983
ANESTHESIA APPARATUS PH-35
K830159 · BSZ
W.E. Leder Enterprises, Inc.
Anesthesiology · 55d
Cleared Mar 09, 1983
ANESTHESIA APPARATUS #FO 20S
K830160 · BSZ
W.E. Leder Enterprises, Inc.
Anesthesiology · 55d
Cleared Mar 09, 1983
ANESTHESIA APATATUS #D-25
K830161 · BSZ
W.E. Leder Enterprises, Inc.
Anesthesiology · 55d
Cleared Mar 09, 1983
UNIV. KNEE, CUTTING INSTRUMENTATION
K830185
Intermedics Orthopedics
General & Plastic Surgery · 49d
Cleared Mar 09, 1983
CAT 3040
K830193 · KPE
Burron Medical Products, Inc.
General Hospital · 48d
Cleared Mar 09, 1983
AFT SYSTEM III
K830214 · DHN
Calbiochem-Behring Corp.
Immunology · 44d
Cleared Mar 09, 1983
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
K830215 · HLJ
Jedmed Instrument Co.
Ophthalmic · 44d
Cleared Mar 09, 1983
DORC COMPACT MICRO SURGICAL SYSTEM
K830216 · HQE
Jedmed Instrument Co.
Ophthalmic · 44d
Cleared Mar 09, 1983
SHERIDAN/ESOPHAGEAL STETHOSCOPE
K830218 · BZW
Sheridan Catheter Corp.
Anesthesiology · 44d
Cleared Mar 09, 1983
ROENTGENOGRAPHY SET
K830229 · DGD
Mallinckrodt Critical Care
Immunology · 44d
Cleared Mar 09, 1983
TRACTION ACCESSORIES
K830244 · HST
Warm & Form, Orthopedic Materials
Neurology · 43d
Cleared Mar 09, 1983
HEAD HALTER
K830245 · ILZ
Warm & Form, Orthopedic Materials
Physical Medicine · 43d
Cleared Mar 09, 1983
OSTEOTOMY BONE STAPLE
K830255 · HXJ
Techmedica, Inc.
Orthopedic · 43d
Cleared Mar 09, 1983
REGNELL HYDRAULIC FEMORAL PROTHESIS
K830285 · KFX
Besco Financial Service
Physical Medicine · 41d
Cleared Mar 09, 1983
ZIMMER SKIN PROTECTOR
K830287 · GAD
Zimmer, Inc.
General & Plastic Surgery · 41d
Cleared Mar 09, 1983
DORC CONTACT/PHOTO DERATOSCOPE
K830290 · HJA
Jedmed Instrument Co.
Ophthalmic · 41d
Cleared Mar 09, 1983
DORC CORNEAL PUNCH BLOCK
K830335 · HNJ
Jedmed Instrument Co.
Ophthalmic · 36d