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
133081–133104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1988
RUBEOLA TEST
K884004 · GRE
Gull Laboratories, Inc.
Microbiology · 75d
Cleared Dec 05, 1988
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
K884005 · DTB
Medtronic Vascular
Cardiovascular · 75d
Cleared Dec 05, 1988
HEMAT 12
K884006 · GKZ
Texas Intl. Laboratories, Inc.
Hematology · 75d
Cleared Dec 05, 1988
USCI TANDEM ADAPTER
K884200 · DTL
C.R. Bard, Inc.
Cardiovascular · 60d
Cleared Dec 05, 1988
INTERSEPT* PREBYPASS FILTER
K884244 · KRJ
Medtronic Blood Systems, Inc.
Cardiovascular · 55d
Cleared Dec 05, 1988
FILTRAL TM 8 HEMODIALYZER
K884326 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 52d
Cleared Dec 05, 1988
GASTROSTOMY FEEDING DEVICE
K884439 · KNT
Southside Biotechnology
Gastroenterology & Urology · 45d
Cleared Dec 05, 1988
MAXITHINS REGULAR PADS, DEODORANT
K884444 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 45d
Cleared Dec 05, 1988
MAXITHINS PANTY SHIELDS, DEODORANT
K884445 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 45d
Cleared Dec 05, 1988
CHELON-FIL
K884475 · EMA
Espe GmbH (Us)
Dental · 41d
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