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

Filters: Cleared only ×
175,820 results
133681–133704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1988
MT/S (SPINE TRANSMIT COIL)
K884606 · LNH
Diasonics, Inc.
Radiology · 31d
Cleared Dec 05, 1988
TEMPOROMANDIBULAR JOINT COIL (TMJ)
K884743 · LNH
Diasonics, Inc.
Radiology · 21d
Cleared Dec 05, 1988
MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.
K884761 · GQN
Difco Laboratories, Inc.
Microbiology · 21d
Cleared Dec 02, 1988
KLEIN HANDLE
K881783 · GDM
E.L. Medico Intl., Inc.
General & Plastic Surgery · 220d
Cleared Dec 02, 1988
KLEIN NEEDLE
K881784 · GDM
E.L. Medico Intl., Inc.
General & Plastic Surgery · 219d
Cleared Dec 02, 1988
CONFIDENCE(TM) STERILE, DISP., LATEX SURG. GLOVES
K882431 · KGO
Charise Charles, Ltd.
General Hospital · 171d
Cleared Dec 02, 1988
DELFIA TRIIODOTHYRONINE (T3) KIT
K883810 · CDP
Pharmacia, Inc.
Chemistry · 85d
Cleared Dec 02, 1988
INTRODUCING CATHETER
K883933 · DYB
Devices For Vascular Intervention, Inc.
Cardiovascular · 78d
Cleared Dec 02, 1988
MODIFICATION OF THE CEDIA DIGOXIN ASSAY
K884054 · KXT
Microgenics Corp.
Chemistry · 67d
Cleared Dec 02, 1988
INTERIM, TEMPORARY CEMENT
K884081 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 66d
Cleared Dec 02, 1988
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K884085 · JHY
Hybritech, Inc.
Chemistry · 66d
Cleared Dec 02, 1988
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
K884125 · JTC
Bio-Tek Instruments, Inc.
Chemistry · 63d
Cleared Dec 02, 1988
NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER
K884143 · CHL
Nova Biomedical Corp.
Chemistry · 63d
Cleared Dec 02, 1988
RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO
K884207 · DHA
Abbott Laboratories
Chemistry · 57d
Cleared Dec 02, 1988
CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.
K884412 · LBK
Valleylab, Inc.
Neurology · 43d
Cleared Dec 02, 1988
CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR
K884413 · LBK
Valleylab, Inc.
Neurology · 43d
Cleared Dec 02, 1988
ALWAYS UNSCENTED MENSTRUAL PADS
K884428 · HHD
Procter & Gamble Co.
Obstetrics & Gynecology · 43d
Cleared Dec 02, 1988
ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD
K884429 · HHL
Procter & Gamble Co.
Obstetrics & Gynecology · 43d
Cleared Dec 02, 1988
HEXASCAN HANDPIECE FOR ARGON/DYE LASER
K884431 · GEX
California Laboratories, Inc.
General & Plastic Surgery · 42d
Cleared Dec 02, 1988
MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85
K884436 · KSE
Harris Mfg. Co.
Chemistry · 42d
Cleared Dec 02, 1988
VISION LYTE (TM) POTASSIUM
K884566 · CEM
Abbott Laboratories
Chemistry · 31d
Cleared Dec 01, 1988
ADD-ON TO CRITICAL PATIENT CARE BED
K882177 · IOQ
Cardio Systems, Inc.
Physical Medicine · 191d
Cleared Dec 01, 1988
CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES
K882469 · HRX
Orthoconcept, Inc.
Orthopedic · 169d
Cleared Dec 01, 1988
AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT
K883122 · JWH
Depuy, Inc.
Orthopedic · 128d