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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92953–92976 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 1997
QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)
K972618 · DMN
Phamatech
Toxicology · 28d
Cleared Aug 08, 1997
BACTEC MYCO/F-SPUTA CULTURE VIALS
K972758 · MDB
Becton Dickinson Microbiology Systems
Microbiology · 53d
Cleared Aug 07, 1997
QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT
K964616 · LPH
Whiteside Biomechanics, Inc.
Orthopedic · 287d
Cleared Aug 07, 1997
RANSFORD CERVICAL FIXATION SYSTEM
K965221 · KWP
Surgicraft , Ltd.
Orthopedic · 219d
Cleared Aug 07, 1997
JMS AV FISTULA NEEDLE
K970962 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 143d
Cleared Aug 07, 1997
ACCURUN 120 HAV IGG POSITIVE CONTROL
K971406 · JJY
Boston Biomedica, Inc.
Microbiology · 113d
Cleared Aug 07, 1997
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
K971715 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Aug 07, 1997
ENDOPATH RESPOSABLE TROCAR SYSTEM
K971738 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Aug 07, 1997
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
K971807 · ESD
Hear-Right, Inc.
Ear, Nose, Throat · 84d
Cleared Aug 07, 1997
RECOVERY PROTRUSIO CAGE
K971890 · JDI
Biomet, Inc.
Orthopedic · 77d
Cleared Aug 07, 1997
INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER
K971922 · MBI
Innovasive Devices, Inc.
Orthopedic · 76d
Cleared Aug 07, 1997
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
K972307 · JJY
Boston Biomedica, Inc.
Microbiology · 49d
Cleared Aug 07, 1997
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K972716 · CIG
Synermed, Inc.
Chemistry · 17d
Cleared Aug 06, 1997
HI-TEC CO2 INSUFFLATOR TYPE 1300
K955477 · HIF
Hi Tec Medical Vertriebs-GmbH Fur...
Obstetrics & Gynecology · 615d
Cleared Aug 06, 1997
AMR MINI-LAPAROSCOPE
K962777 · HET
Applied Medical Resources
Obstetrics & Gynecology · 385d
Cleared Aug 06, 1997
MODEL HS-2 TENS DEVICE
K962951 · GZJ
Technalithics Laboratories, Inc.
Neurology · 376d
Cleared Aug 06, 1997
COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
K963290 · IYO
Endosonics Corp.
Radiology · 350d
Cleared Aug 06, 1997
IMZ TWIN PLUS - CYLINDER
K963521 · DZE
Imz, GmbH
Dental · 337d
Cleared Aug 06, 1997
FLEXILOG LS
K964804 · KLA
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 250d
Cleared Aug 06, 1997
TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)
K970014 · JOW
Delphi Consulting Group
Cardiovascular · 216d
Cleared Aug 06, 1997
MDILOG, MODEL MDC-511
K970344 · CAF
Medtrak Technologies, Inc.
Anesthesiology · 189d
Cleared Aug 06, 1997
PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED)
K971629 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 96d
Cleared Aug 06, 1997
IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED
K971705 · JDI
Implex Corp.
Orthopedic · 90d
Cleared Aug 06, 1997
BARD COMPOSITE PROSTHESIS
K971745 · FTL
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 86d