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
86089–86112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
K990984 · JJX
Ortho-Clinical Diagnostics, Inc.
Immunology · 15d
Cleared Apr 07, 1999
ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
K981191 · DQY
Intratherapeutics, Inc.
Cardiovascular · 370d
Cleared Apr 07, 1999
SMARTVENT 201 PORTABLE VENTILATOR
K981668 · CBK
Versamed , Ltd.
Anesthesiology · 331d
Cleared Apr 07, 1999
EMS MOUTH TO MASK RESUSCITATORS
K983919 · CBP
Engineered Medical Systems
Anesthesiology · 154d
Cleared Apr 07, 1999
CLEARPLAN EASY HOME PREGNANCY TEST
K990262 · LCX
Unipath , Ltd.
Chemistry · 70d
Cleared Apr 07, 1999
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
K990587 · DHR
Bio-Rad
Immunology · 43d
Cleared Apr 07, 1999
MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
K990888 · JJY
Bio-Rad
Chemistry · 28d
Cleared Apr 07, 1999
SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED...
K990970 · IYN
Medison America, Inc.
Radiology · 15d
Cleared Apr 06, 1999
SHARPS COLLECTION CONTAINER - SAF-T-SHELL
K982029 · FMI
American Medical Mfg., Inc.
General Hospital · 301d
Cleared Apr 06, 1999
MEDEX 3000 SERIES SYRINGE INFUSION PUMP
K982640 · FRN
Medex, Inc.
General Hospital · 251d
Cleared Apr 06, 1999
'ECURLINE UMBILICAL CORD CLAMP #3500
K990737 · HFW
Precision Dynamics Corp.
Obstetrics & Gynecology · 32d
Cleared Apr 06, 1999
IPS D.SIGN PORCELAIN
K990817 · EIH
Ivoclar North America, Inc.
Dental · 26d
Cleared Apr 06, 1999
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
K990863 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 21d
Cleared Apr 06, 1999
IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
K990886 · DCK
Diagnostic Products Corp.
Immunology · 20d
Cleared Apr 06, 1999
PRODIGY 4
K990898 · EBF
Sybron Dental Specialties, Inc.
Dental · 19d
Cleared Apr 05, 1999
SMARTBOND
K981036 · DYH
Gac Intl., Inc.
Dental · 382d
Cleared Apr 05, 1999
ANGIO-CT MIYABI
K990491 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 47d
Cleared Apr 05, 1999
GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH
K990567 · FRG
Global Healthcare, Inc.
General Hospital · 41d
Cleared Apr 04, 1999
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
K990064 · HQR
Ophthalmic Technologies, Inc.
Ophthalmic · 86d
Cleared Apr 04, 1999
S.P.A.R STERILE AMBULATORY RESERVOIR
K990091 · MRZ
Faulding Pharmaceutical Co.
General Hospital · 83d
Cleared Apr 02, 1999
SECOND WIND AIR PURIFIER
K980745 · FRA
Monagan Ent., Inc.
General Hospital · 400d
Cleared Apr 02, 1999
FOCUS PILOT CONTOURING WORKSTATION
K981535 · IYE
Computerized Medical Systems, Inc.
Radiology · 338d
Cleared Apr 02, 1999
ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT...
K982505 · LYY
Tillotson Healthcare Corp.
General Hospital · 256d
Cleared Apr 02, 1999
SPQ TEST SYSTEM
K982708 · DFC
DiaSorin, Inc.
Chemistry · 241d