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
93097–93120 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
K971604 · DSH
Alexander Mfg. Co.
Cardiovascular · 88d
Cleared Jul 28, 1997
SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
K971695 · FMT
Fisher & Paykel Electronics , Ltd.
General Hospital · 81d
Cleared Jul 28, 1997
FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)
K971744 · FXX
Berkley Medical Resources, Inc.
General Hospital · 77d
Cleared Jul 28, 1997
POWDER-FREE PATIENT EXAMINATION GLOVES
K971949 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 61d
Cleared Jul 28, 1997
FOSFOMYCIN, 200 MG, SENSI-DISC
K972098 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 54d
Cleared Jul 28, 1997
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES
K972291 · LYY
Allegiance Healthcare Corp.
General Hospital · 39d
Cleared Jul 28, 1997
TINAQUANT MYOGLOBIN ASSAY
K972513 · DDR
Boehringer Mannheim Corp.
Immunology · 21d
Cleared Jul 28, 1997
DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)
K972528 · FPO
Dyna Corp.
General Hospital · 21d
Cleared Jul 28, 1997
CARDIAC STATUS CONTROLS/TROPONIN I
K972687 · JJX
Spectral Diagnostics, Inc.
Chemistry · 11d
Cleared Jul 25, 1997
ELECSYS PSA ASSAY
K964351 · LTJ
Boehringer Mannheim Corp.
Immunology · 266d
Cleared Jul 25, 1997
PERCUTANEOUS VENOUS INTRODUCER 10264
K965167 · DYB
Medamicus, Inc.
Cardiovascular · 213d
Cleared Jul 25, 1997
ARROW-TREROTOLA PTD CATHETER
K970080 · MCW
Arrow Intl., Inc.
Cardiovascular · 197d
Cleared Jul 25, 1997
ANNULOFLO SYSTEM
K970375 · KRH
Carbomedics, Inc.
Cardiovascular · 172d
Cleared Jul 25, 1997
VIBRA-SURGE SYSTEM MODEL VS2120
K971533 · LFL
Sonics & Materials, Inc.
General & Plastic Surgery · 88d
Cleared Jul 25, 1997
PROTEGE LIQUID OXYGEN SYSTEM
K971545 · BYJ
Healthdyne Technologies, Inc.
Anesthesiology · 88d
Cleared Jul 25, 1997
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND...
K971660 · FDS
Olympus America, Inc.
Radiology · 80d
Cleared Jul 25, 1997
RAMY PISTON SYRINGE
K971664 · FMF
Alshifa Medical Syringes Mfg. Co., Ltd.
General Hospital · 80d
Cleared Jul 25, 1997
IMMULITE FREE T4 (2-STEP)
K971792 · CEC
Diagnostic Products Corp.
Chemistry · 71d
Cleared Jul 25, 1997
SUCTION INSTRUMENTATION
K972074 · GCX
Walter Lorenz Surgical, Inc.
General Hospital · 52d
Cleared Jul 25, 1997
VON WILLEBRAND REAGENT
K972116 · GGP
Behring Diagnostics, Inc.
Hematology · 50d
Cleared Jul 25, 1997
PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905
K972123 · FMQ
Smith
General Hospital · 50d
Cleared Jul 25, 1997
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
K972144 · JBQ
Sigma Diagnostics, Inc.
Hematology · 49d
Cleared Jul 25, 1997
POCKET COUNT OR SAFETCOUNT
K972302 · LWH
Sage Products, Inc.
General & Plastic Surgery · 36d
Cleared Jul 25, 1997
CARDIAC STATUS CONTROLS
K972408 · JJT
Spectral Diagnostics, Inc.
Chemistry · 29d