FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134473–134496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)
K883616 · DHB
Diagnostic Products Corp.
Immunology · 29d
Cleared Sep 22, 1988
QM300 CALIBRATOR F PACK
K883711 · DFC
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 23d
Cleared Sep 22, 1988
QM300 CONTROL F PACK
K883712 · DFC
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 23d
Cleared Sep 22, 1988
AXIAL COMPRESSION SCREW
K883715 · KTT
Straub Clinic and Hospital
Orthopedic · 22d
Cleared Sep 21, 1988
KING KONDOM (CONDOM)
K882009 · HIS
King Kondom Products, Inc.
Obstetrics & Gynecology · 131d
Cleared Sep 21, 1988
MEDACORD PVL, PERSONAL VASCULAR LABORATORY
K882018 · JAF
Medasonics, Inc.
Radiology · 131d
Cleared Sep 21, 1988
CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K882867 · KNT
Corpak Co.
Gastroenterology & Urology · 72d
Cleared Sep 20, 1988
HOLTER SCANNER
K881488 · DSI
Cardiodata Corp.
Cardiovascular · 165d
Cleared Sep 20, 1988
HEART HUGGER STERNUM SUPPORT HARNESS
K882592 · KMO
General Cardiac Technology, Inc.
General Hospital · 89d
Cleared Sep 20, 1988
THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM
K882594 · FRN
Omni-Flow, Inc.
General Hospital · 88d
Cleared Sep 20, 1988
PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS.
K882654 · GEY
Surgical Innovators of America, Inc.
General & Plastic Surgery · 83d
Cleared Sep 20, 1988
JOBST EXTREMITY PUMP(R) SYSTEM 7500
K882683 · JOW
Jobst Institute, Inc.
Cardiovascular · 82d
Cleared Sep 20, 1988
TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)
K882761 · HIH
Intramed Laboratories, Inc.
Obstetrics & Gynecology · 76d
Cleared Sep 20, 1988
Q-CATH RM
K883031 · DXJ
Quinton, Inc.
Cardiovascular · 63d
Cleared Sep 20, 1988
QUIK-PACE II ELECTRODES
K883121 · DRO
Physio-Control Corp.
Cardiovascular · 56d
Cleared Sep 19, 1988
MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A
K875179 · DPW
Tsi, Inc.
Cardiovascular · 277d
Cleared Sep 19, 1988
MODEL #1551 SWITCH CONTROL INTERFACE UNIT
K880360 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
MODEL #1552 ATTENDANT CONTROL OPTION
K880361 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
MODEL #1553 RECLINER INTERFACE
K880362 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
MODEL #1554 PNEUMATIC SWITCH
K880363 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
MODEL #1555 REMOTE JOYSTICK
K880364 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
MODEL #1556 HEAVY-DUTY JOYSTICK
K880365 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
ELECTROSTIMULATOR MODEL 808
K880426 · GZJ
Cornell Enterprises Co., Inc.
Neurology · 231d
Cleared Sep 19, 1988
PXI (PERSONAL X-RAY IMAGER) 512
K881993 · LLZ
Oklahoma Digital Technologies, Inc.
Radiology · 130d