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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
40033–40056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132256 · PSZ
Becton, Dickinson and Company
Microbiology · 19d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132259 · PSZ
Becton, Dickinson and Company
Microbiology · 19d
Cleared Aug 06, 2013
OVUSENSE
K122337 · LHD
Fertility Focus, Ltd.
Obstetrics & Gynecology · 369d
Cleared Aug 06, 2013
BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET
K123047 · FCX
Bracco Diagnostic, Inc.
Gastroenterology & Urology · 312d
Cleared Aug 06, 2013
CLEARSPEC SINGLE USE VAGINAL SPECULUM
K130046 · HIB
Clearspec, LLC
Obstetrics & Gynecology · 210d
Cleared Aug 06, 2013
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
K130126 · MBF
Biomet, Inc.
Orthopedic · 201d
Cleared Aug 06, 2013
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0
K130743 · LLZ
Ortho Kinematics, Inc.
Radiology · 140d
Cleared Aug 06, 2013
FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X...
K131450 · LOX
Ostial Corporation
Cardiovascular · 78d
Cleared Aug 06, 2013
MENICON NECT CONTACT LENS CASE
K131875 · LRX
Foresight Regulatory Strategies
Ophthalmic · 43d
Cleared Aug 06, 2013
CD HORIZON SPINAL SYSTEM
K132111 · NKB
Medtronic Sofamor Danek USA
Orthopedic · 28d
Cleared Aug 05, 2013
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553 · GKR
ACON Laboratories, Inc.
Hematology · 349d
Cleared Aug 05, 2013
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
K122610 · BYE
Sen MU Technology Co., Ltd.
Anesthesiology · 343d
Cleared Aug 05, 2013
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE...
K122883 · JWH
Stelkast Company
Orthopedic · 319d
Cleared Aug 05, 2013
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
K130342 · LPL
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 175d
Cleared Aug 05, 2013
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
K130541 · HAE
Symmetry Surgical
Neurology · 157d
Cleared Aug 05, 2013
PRIMATRIX DERMAL REPAIR SCAFFOLD
K131286 · KGN
Tei Biosciences, Inc.
General & Plastic Surgery · 91d
Cleared Aug 05, 2013
EPIDOSE
K131704 · IYE
Sun Nuclear Corporation
Radiology · 55d
Cleared Aug 05, 2013
JBAIDS ANTHRAX DETECTION KIT
K131930 · NHT
Biofire Diagnostics, Inc.
Microbiology · 39d
Cleared Aug 05, 2013
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
K132190 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 21d
Cleared Aug 04, 2013
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · OLO
Smith & Nephew, Inc.
Orthopedic · 138d
Cleared Aug 02, 2013
VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
K121370 · FHO
Vectec
Gastroenterology & Urology · 452d
Cleared Aug 02, 2013
INTELLISAVE AX700 ANESTHESIA SYSTEM
K122063 · BSZ
Philips Anesthesia Care
Anesthesiology · 385d
Cleared Aug 02, 2013
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
K123347 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 275d
Cleared Aug 02, 2013
SOLUTIS
K130933 · HQF
Quantel Medical
Ophthalmic · 120d