FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133873–133896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1988
PARKER BATHING SYSTEM
K883308 · ILJ
Mid-Canada Medical
Physical Medicine · 48d
Cleared Sep 22, 1988
QUIDEL PREGNANCY TEST CONTROL
K883316 · JJX
Quidel Corp.
Chemistry · 48d
Cleared Sep 22, 1988
VISTA MR 2055 HP SYSTEM
K883378 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 44d
Cleared Sep 22, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN A
K883492 · CZP
Technicon Instruments Corp.
Immunology · 37d
Cleared Sep 22, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN M
K883493 · DFL
Technicon Instruments Corp.
Immunology · 37d
Cleared Sep 22, 1988
HERA H
K883508 · EJT
Degussa Dental, Inc.
Dental · 36d
Cleared Sep 22, 1988
HERAEUS DG 63
K883509 · EJS
Degussa Dental, Inc.
Dental · 36d
Cleared Sep 22, 1988
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
K883515 · DCN
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 36d
Cleared Sep 22, 1988
EVENT MARKER & A SECOND PRESSURE TREND OUTPUT
K883518 · GWM
Metatech Corp.
Neurology · 37d
Cleared Sep 22, 1988
COMPEED ATHLETIC DRESSING
K883588 · FRO
Coloplast A/S
General & Plastic Surgery · 31d
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