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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
92449–92472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 06, 1997
VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
K971837 · HET
CooperSurgical, Inc.
Obstetrics & Gynecology · 79d
Cleared Aug 06, 1997
ENDOVIEW SPPHIRE LENS SET
K971853 · HJK
American Medical Devices, Inc.
Ophthalmic · 78d
Cleared Aug 06, 1997
AMSINO URINARY LEG BAG
K971929 · KNX
Amsino Intl., Inc.
Gastroenterology & Urology · 71d
Cleared Aug 06, 1997
SMITH & NEPHEW SUTURE COLLET
K971939 · OCW
Smith & Nephew Endoscopy, Inc.
Gastroenterology & Urology · 71d
Cleared Aug 06, 1997
PATIENT RESTRAINT
K971948 · FMQ
E.M. Adams Co., Inc.
General Hospital · 70d
Cleared Aug 06, 1997
TOM CAT F.L., TOM CAT S.L.
K972245 · MFD
A & A Medical, Inc.
Obstetrics & Gynecology · 51d
Cleared Aug 06, 1997
CYTOPLAST REGENTEX TITANIUM 250
K972278 · LYC
Osteogenics Co.
Dental · 49d
Cleared Aug 06, 1997
AQ ONE STEP COCAINE TEST
K972384 · DIO
Bionike Laboratories, Inc.
Toxicology · 41d
Cleared Aug 06, 1997
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K972609 · LCQ
Bio-Rad
Hematology · 26d