FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
85081–85104 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1999
CORTICAL MAPPING UNIT, MODEL CMU
K992194 · GYC
Ad-Tech Medical Instrument Corp
Neurology · 76d
Cleared Sep 13, 1999
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER...
K992307 · MQF
Fertility Technology Resources, Inc.
Obstetrics & Gynecology · 66d
Cleared Sep 13, 1999
OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
K992308 · MQE
Lifetek Medical, Inc.
Obstetrics & Gynecology · 66d
Cleared Sep 13, 1999
K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC
K992311 · DCK
Kamiya Biomedical Co.
Chemistry · 66d
Cleared Sep 13, 1999
K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
K992312 · DCK
Kamiya Biomedical Co.
Immunology · 66d
Cleared Sep 13, 1999
ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING...
K992417 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 55d
Cleared Sep 13, 1999
ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH...
K992418 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 55d
Cleared Sep 13, 1999
ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH...
K992419 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 55d
Cleared Sep 13, 1999
COLLINS CPL
K992743 · BZG
Collins Medical, Inc.
Anesthesiology · 28d
Cleared Sep 13, 1999
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P,...
K992803 · CHH
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Sep 10, 1999
BARD BALLOON INFLATION SYSTEM
K991375 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 10, 1999
TRI-POLAR SYSTEM
K991990 · KWY
Biomet, Inc.
Orthopedic · 88d
Cleared Sep 10, 1999
DUPEL IONTOPHORESIS SYSTEM
K991991 · EGJ
Empi
Physical Medicine · 88d
Cleared Sep 10, 1999
TWILIGHT
K991994 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 88d
Cleared Sep 10, 1999
SYNEA-HS HIGH SPEED-HANDPIECE
K992011 · EFB
A-Dec, Inc.
Dental · 87d
Cleared Sep 10, 1999
FREEDOM INFUSION SYSTEM
K992015 · MEB
Novacon Corp.
General Hospital · 87d
Cleared Sep 10, 1999
BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
K992196 · FLD
Hemocleanse, Inc.
Gastroenterology & Urology · 72d
Cleared Sep 10, 1999
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
K992210 · LZA
Safeskin Corp.
General Hospital · 71d
Cleared Sep 10, 1999
CHRISTOUDIAS SLIM TIP ELECTRODE INSERT
K992345 · GEI
Innervision, Inc.
General & Plastic Surgery · 89d
Cleared Sep 10, 1999
CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)
K992358 · LYY
Biopro (M) Sdn Bhd
General Hospital · 58d
Cleared Sep 10, 1999
BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
K992588 · LZA
Formosa Glove Industrial Co., Ltd.
General Hospital · 39d
Cleared Sep 10, 1999
THERMALIGHT 2000
K992630 · GEX
Jennifermaxx, Inc.
General & Plastic Surgery · 87d
Cleared Sep 10, 1999
RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90
K992693 · GEI
Rita Medical Systems
General & Plastic Surgery · 29d
Cleared Sep 10, 1999
MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
K992694 · KZM
Myotronics-Noromed, Inc.
Dental · 29d