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
123769–123792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1990
SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER
K902778 · HRX
Surgical Dynamics, Inc.
Orthopedic · 127d
Cleared Oct 30, 1990
OSTEONICS DRM ACETABULAR COMPONENT
K903636 · JDI
Osteonics Corp.
Orthopedic · 78d
Cleared Oct 30, 1990
QUALTEX NEEDLE COUNTERS
K903947 · MMK
Deroyal Industries, Inc.
General Hospital · 64d
Cleared Oct 30, 1990
STI DRAPE SHEET STYLE 1908
K904112 · KKX
Sterilizer Technologies Corp.
General Hospital · 54d
Cleared Oct 30, 1990
OPERATIVE RECORDING CAMERA
K904113 · IKO
Medical Dynamics, Inc.
Physical Medicine · 54d
Cleared Oct 30, 1990
VISIRASER
K904126 · GEX
Acorn Group, Inc.
General & Plastic Surgery · 54d
Cleared Oct 30, 1990
MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP
K904578 · GET
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Oct 30, 1990
ACCU PATH STERILE LABEL
K904598 · LDQ
Accu-Path
General & Plastic Surgery · 20d
Cleared Oct 29, 1990
PREEMICARE NEBUTECH NEBULIZER SYSTEM
K896375 · CAF
Preemicare Corp.
Anesthesiology · 357d
Cleared Oct 29, 1990
PROMATRON 3000
K901566 · IKK
Promatek Medical Systems, Inc.
Physical Medicine · 209d
Cleared Oct 29, 1990
ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION
K902079 · KPE
Chartermed, Inc.
General Hospital · 174d
Cleared Oct 29, 1990
G.E. 48-4 CEILING TUBEHANGER
K902791 · KPR
Electromek Diagnostic Systems, Inc.
Radiology · 125d
Cleared Oct 29, 1990
G.E. MONITROL 90 AND G.E. MONITROL 15
K902989 · IXR
Electromek Diagnostic Systems, Inc.
Radiology · 125d
Cleared Oct 29, 1990
SOPHYCAMERA DSM 315
K903030 · IYX
Provino
Radiology · 111d
Cleared Oct 29, 1990
OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR
K903445 · LBI
Olympic Medical Corp.
General Hospital · 90d
Cleared Oct 29, 1990
CT GUIDE (TM)
K903622 · JAK
Radi Medical Systems AB
Radiology · 81d
Cleared Oct 29, 1990
NON-STERILE LATEX DENTAL PROCEDURE GLOVES
K903857 · LYY
Formtex Medical Sdn. Bhd.
General Hospital · 70d
Cleared Oct 29, 1990
'TDXFLX ANALYZER
K904226 · LCQ
Abbott Laboratories
Chemistry · 46d
Cleared Oct 29, 1990
CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST
K904498 · DHR
Biotrax, Inc.
Immunology · 27d
Cleared Oct 29, 1990
QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE
K904637 · JPK
R&D Systems, Inc.
Hematology · 18d
Cleared Oct 26, 1990
THE MURRAY MOBILIFT(TM)
K895677 · FNG
Medical/Surgical Specialties, Ltd.
General Hospital · 401d
Cleared Oct 26, 1990
PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN
K900313 · CBK
Percussionaire Corp.
Anesthesiology · 277d
Cleared Oct 26, 1990
PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN
K900314 · CBK
Percussionaire Corp.
Anesthesiology · 277d
Cleared Oct 26, 1990
PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN
K900315 · CBK
Percussionaire Corp.
Anesthesiology · 277d