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
139825–139848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1987
TOMTEC GRAM STAINER CRYSTAL VIOLET
K871532 · JTS
Remel Co.
Pathology · 9d
Cleared Apr 29, 1987
TOMTEC GRAM STAINER DECOLORIZER
K871533 · PPM
Remel Co.
Pathology · 9d
Cleared Apr 29, 1987
MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
K871541 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 9d
Cleared Apr 29, 1987
METHYL GREEN SOLUTION
K871544 · HZA
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Apr 29, 1987
NEW FUCHSIN SOLUTION
K871545 · IDF
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Apr 28, 1987
GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT
K864643 · LCP
Pacific Hemostasis
Hematology · 153d
Cleared Apr 28, 1987
MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20
K870067 · DQY
Vygon Corp.
Cardiovascular · 110d
Cleared Apr 28, 1987
CLEARVIEW CW-10
K870210 · GKR
Clearview Instruments, Inc.
Hematology · 98d
Cleared Apr 28, 1987
TOXOPLASMA IGM MICROASSAY
K870753 · LGD
Diamedix Corp.
Microbiology · 61d
Cleared Apr 28, 1987
THORASTAT ATR-XXXX
K870792 · DTP
Gish Biomedical, Inc.
Cardiovascular · 61d
Cleared Apr 28, 1987
BACTO(R) STREP GROUP KIT
K870854 · GTZ
Difco Laboratories, Inc.
Microbiology · 56d
Cleared Apr 28, 1987
CRYOSURGICAL PROBE
K871314 · GEH
Western Medical Research
General & Plastic Surgery · 27d
Cleared Apr 28, 1987
VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU.
K871331 · DHB
Ventrex Laboratories, Inc.
Immunology · 25d
Cleared Apr 28, 1987
CB-7 ELECTRONIC EPILATOR
K871372 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 21d
Cleared Apr 27, 1987
'EXMOOR' DAS GUPTA LARYNGEAL KEEL
K864936 · FWN
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 132d
Cleared Apr 27, 1987
CENTRAL VENOUS CATHETER
K870075 · DQY
Bd Becton Dickinson Vacutainer...
Cardiovascular · 109d
Cleared Apr 27, 1987
#014160-TAB TUBING ROTATOR ADAPTOR
K870325 · DTL
Clinical Connections, Inc.
Cardiovascular · 89d
Cleared Apr 27, 1987
VASCATH VASCULAR CATHETER PLACEMENT KIT
K870542 · DYB
Titan Medical, Inc.
Cardiovascular · 77d
Cleared Apr 27, 1987
BPA CARDIOVASCULAR PRESSURE AMPLIFIER
K870783 · DRQ
Fisher Imaging Corp.
Cardiovascular · 60d
Cleared Apr 27, 1987
PACEMAKER FUNCTION ANALYZER
K870909 · KRE
Paceart, Inc.
Cardiovascular · 53d
Cleared Apr 27, 1987
SCHIRMER NYLON SUTURE LASER LENS
K871099 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 39d
Cleared Apr 27, 1987
INTRA-ARTICULATED ARTHRO POWER SYSTEM
K871250 · KIT
Richard Wolf Medical Instruments Corp.
Pathology · 28d
Cleared Apr 27, 1987
KNIFE, OPHTHALMIC
K871285 · HNN
Trueline Instruments, Inc.
Ophthalmic · 27d
Cleared Apr 27, 1987
SDI TOTAL HIP SYSTEM
K871299 · JDI
Orthomet, Inc.
Orthopedic · 27d