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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
98977–99000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1996
OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT
K955139 · JMO
Olympus America, Inc.
Chemistry · 91d
Cleared Feb 12, 1996
B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
K955235 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 90d
Cleared Feb 12, 1996
MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM
K955245 · HQC
Mentor O & O, Inc.
Ophthalmic · 89d
Cleared Feb 12, 1996
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
K955407 · LJT
Sims Deltec, Inc.
General Hospital · 77d
Cleared Feb 12, 1996
ULTRASOUND PROBE BIOPSY ACCESSORIES
K955458 · ITX
Biosound, Inc.
Radiology · 75d
Cleared Feb 12, 1996
ALPHA MICRON 20 MICROAGGREGATE FILTER
K955515 · CAK
Alpha Therapeutic Corp.
General Hospital · 70d
Cleared Feb 12, 1996
JPI AUTOMATIC X-RAY FILM PROCESSOR
K955706 · IXW
Jpi Healthcare Co, Ltd.
Radiology · 59d
Cleared Feb 12, 1996
WIDEX MODEL SENSO DIGITAL (C8)
K955878 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 46d
Cleared Feb 09, 1996
SALTIME VISCOMETER
K936006 · LHZ
Harold J. Kosasky, M.D.
Obstetrics & Gynecology · 786d
Cleared Feb 09, 1996
PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM
K942210 · MNS
Puritan Bennett Corp.
Anesthesiology · 647d
Cleared Feb 09, 1996
ULTRASOUND SCANNER 2002
K943315 · IYO
B&K Medical
Radiology · 578d
Cleared Feb 09, 1996
AMBULATORY (HOLTER) RECORDING SYSTEM
K950723 · DQK
Biosensor Corp.
Cardiovascular · 358d
Cleared Feb 09, 1996
CD LIBERTY POSTERIOR SPINCAL SYSTEM
K951164 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 332d
Cleared Feb 09, 1996
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
K952337 · LCP
Roche Diagnostic Systems, Inc.
Hematology · 266d
Cleared Feb 09, 1996
CARDIOLIPIN IGM EIA TEST SYSTEM
K952521 · MID
Immunoprobe, Inc.
Immunology · 253d
Cleared Feb 09, 1996
CARDIOLIPIN IGA EIA TEST SYSTEM
K952522 · MID
Immunoprobe, Inc.
Immunology · 253d
Cleared Feb 09, 1996
CARDIOLIPIN IGG EIA TEST KIT
K952523 · MID
Immunoprobe, Inc.
Immunology · 253d
Cleared Feb 09, 1996
CHROM Z-F:VIII, CAT. NO. 5241
K952668 · GGP
Helena Laboratories
Hematology · 242d
Cleared Feb 09, 1996
UNIMED MEDICAL DISPENSING PUMP
K952967 · FRN
A.Z.E. Medical, Inc.
General Hospital · 227d
Cleared Feb 09, 1996
MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
K953124 · HBL
Ohio Medical Instrument Co., Inc.
Neurology · 219d
Cleared Feb 09, 1996
SUTURE CORD
K953128 · GAS
Phoenix Biomedical Corp.
General & Plastic Surgery · 218d
Cleared Feb 09, 1996
DRAGER INFANT RADIANT WARMERN RH600
K953489 · FMT
Drager, Inc.
General Hospital · 199d
Cleared Feb 09, 1996
BURNAID BURN FIRST AID DRESSING
K953505 · MGQ
Rye Pharmaceuticals Pty. , Ltd.
General & Plastic Surgery · 198d
Cleared Feb 09, 1996
WASHER, BOLT, NUT, ORTHOPEDIC
K954682 · HTN
Linvatec Corp.
Orthopedic · 121d