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
102961–102984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1995
DEPUY DURALOC 100C ACETABULAR CUP
K951674 · LPH
Depuy, Inc.
Orthopedic · 30d
Cleared May 11, 1995
METEL URETERAL BASKET STONE DISLODGER
K951761 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 24d
Cleared May 11, 1995
SERIES 6600 DIGITAL MOBILE C-ARM
K951765 · OXO
Ge Dec Medical Systems
Radiology · 24d
Cleared May 11, 1995
ROSSITER SINUS STENT
K951803 · KAM
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 22d
Cleared May 10, 1995
MASTERSTIM 1-4
K932075 · IPF
Health Care Assoc.
Physical Medicine · 741d
Cleared May 10, 1995
LINVATEC STASYS-PES FIXATION DEVICE
K934321 · HWC
Linvatec Corp.
Orthopedic · 614d
Cleared May 10, 1995
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
K941215 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 426d
Cleared May 10, 1995
BUSE STAFF PROTECTION GOWNS AND KITS
K941845 · FYC
Busse Hospital Disposables, Inc.
General Hospital · 391d
Cleared May 10, 1995
MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND
K942072 · DXN
Mabis Healthcare, Inc.
Cardiovascular · 376d
Cleared May 10, 1995
CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)
K942586 · DXH
Telescan Medical Systems
Cardiovascular · 363d
Cleared May 10, 1995
HOLTER SSR DIGICORDER(TM)
K942653 · DSH
Del Mar Avionics
Cardiovascular · 341d
Cleared May 10, 1995
ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT
K942791 · CAC
Sherwood Medical Co.
Anesthesiology · 330d
Cleared May 10, 1995
HEPARIN MANAGEMENT TEST CARD
K943283 · KFF
Cardiovascular Diagnostics, Inc.
Hematology · 307d
Cleared May 10, 1995
INCLUSIVE ENDOSCOPE
K943356 · HRX
Danek Medical, Inc.
Orthopedic · 302d
Cleared May 10, 1995
FI02 SENSING MODULE
K944120 · CCL
Core-M, L.P.
Anesthesiology · 260d
Cleared May 10, 1995
ELCAT D-PPG, PLETHYSMOGRAPH DEVICE
K944395 · JOM
Dermatology Assoc.
Cardiovascular · 243d
Cleared May 10, 1995
NEONATAL BLOOD COLLECTION AND SCREENING FORM
K944618 · JKA
General Business Forms, Inc.
Chemistry · 232d
Cleared May 10, 1995
PROPAQ 200 MONITOR
K945071 · DRT
Protocol Systems, Inc.
Cardiovascular · 208d
Cleared May 10, 1995
1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED
K945384 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 188d
Cleared May 10, 1995
LARGE MUSCLE STRENGTH GAUGE
K945630 · KQX
J-Tech, Inc.
Neurology · 175d
Cleared May 10, 1995
JPI AUTOMATIC X-RAY FILM PROCESSOR
K950043 · IXW
Jpi Healthcare Co, Ltd.
Radiology · 125d
Cleared May 10, 1995
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
K950208 · GWF
Nihon Kohden America, Inc.
Neurology · 112d
Cleared May 10, 1995
VACUUM SURGE SUPRESSER
K950600 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 90d
Cleared May 10, 1995
ACE SUPRACONDYLAR PLATE
K950618 · HRS
Ace Medical Co.
Orthopedic · 89d