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
148705–148728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1985
ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO
K850012 · LYC
Heyltex Corp.
Dental · 110d
Cleared Apr 22, 1985
ERIS URO-DIAGNOSTIC SYSTEM
K850169 · FFG
Eris Medical Technology
Gastroenterology & Urology · 96d
Cleared Apr 22, 1985
CAFFEIC ACID DISK
K850194 · JSF
Remel Co.
Microbiology · 94d
Cleared Apr 22, 1985
ENDOSOPIC STENE MANIPULATING BALLOON
K850489 · LQR
Mill-Rose Laboratory
Gastroenterology & Urology · 73d
Cleared Apr 22, 1985
KULZER DENTIN ADHESIVE
K850965 · EBF
Kulzer, Inc.
Dental · 45d
Cleared Apr 22, 1985
DENT-DR. VACU-FRAME
K851045 · EIE
Dent-Dr.
Dental · 39d
Cleared Apr 22, 1985
OPAQUER/BONDING AGENT
K851056 · KLE
Dentsply Intl.
Dental · 39d
Cleared Apr 22, 1985
T-SCREW
K851214 · HWC
Northeast Iowa Podiatry
Orthopedic · 27d
Cleared Apr 22, 1985
SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC
K851249 · JSJ
Roche Diagnostic Systems, Inc.
Microbiology · 26d
Cleared Apr 22, 1985
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
K851250 · JSG
Roche Diagnostic Systems, Inc.
Microbiology · 26d
Cleared Apr 22, 1985
OXIDATIVE FORMENTIVE MEDIUM
K851344 · JSH
Micro Media Laboratories
Microbiology · 18d
Cleared Apr 22, 1985
FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP
K851364 · KNW
Precision Dynamics Corp.
Gastroenterology & Urology · 18d
Cleared Apr 19, 1985
VARICELLA-ZOSTER(IGG) IFA TEST
K841434 · GQW
Zeus Scientific, Inc.
Microbiology · 378d
Cleared Apr 19, 1985
TP 1
K844483 · KRG
Vitatron Medical BV
Cardiovascular · 151d
Cleared Apr 19, 1985
CERYX6, 611, CERYX 3 311 & CERYX 1 111
K844485 · KRG
Vitatron Medical BV
Cardiovascular · 151d
Cleared Apr 19, 1985
BIOMETRIC TOTAL HIP SYSTEM
K844787 · JDI
Biomedics
Orthopedic · 130d
Cleared Apr 19, 1985
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K845025 · KWL
Biomet, Inc.
Orthopedic · 113d
Cleared Apr 19, 1985
MEDICAL, DISPOSABLE BEDDING
K850067 · KME
East Texas Lighthouse For the Blind
General Hospital · 101d
Cleared Apr 19, 1985
DIGITAL IMAGE PROCESSOR FP-2C
K850080 · LLZ
Eigen Video
Radiology · 99d
Cleared Apr 19, 1985
FISHER DIAGNOSTICS LATEST-CRP TEST KIT
K850160 · DCK
Fisher Diagnostics
Immunology · 94d
Cleared Apr 19, 1985
LETOURNEL ACETABULAR PLATE
K850401 · HRS
Pfizer, Inc.
Orthopedic · 77d
Cleared Apr 19, 1985
MEC INTRAMEDULLARY ROD
K850441 · HSB
Pfizer, Inc.
Orthopedic · 73d
Cleared Apr 19, 1985
MEC BROAD BONE PLATE
K850442 · HRS
Pfizer, Inc.
Orthopedic · 73d
Cleared Apr 19, 1985
MEC BUTRESS PLATE
K850444 · HRS
Pfizer, Inc.
Orthopedic · 73d