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
90241–90264 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1998
SHARPS PLUS 5 GALLON SHARPS CONTAINER
K980179 · FMI
Rotonics Mfg., Inc.
General Hospital · 83d
Cleared Apr 13, 1998
TELICAM
K980474 · EIA
Dental/Medical Diagnostic Systems, Inc.
Dental · 66d
Cleared Apr 13, 1998
FUJI I
K980695 · EMA
GC America, Inc.
Dental · 49d
Cleared Apr 10, 1998
VAPORIZATION ELECTRODES
K970961 · KNF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 389d
Cleared Apr 10, 1998
CV PERI-GUARD - CARDIOVASCULAR PATCH
K971726 · DXZ
Bio-Vascular, Inc.
Cardiovascular · 336d
Cleared Apr 10, 1998
CO2 PNEUMO-DISSECTOR
K972647 · HET
Cook Urological, Inc.
Obstetrics & Gynecology · 269d
Cleared Apr 10, 1998
FLOW RIDER FLOW DIRECTED MICRO CATHETER
K980104 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 88d
Cleared Apr 10, 1998
ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM
K980110 · GEH
Endocare, Inc.
General & Plastic Surgery · 88d
Cleared Apr 10, 1998
AMT DECOMPRESSION TUBES
K980145 · KGC
Applied Medical Technology, Inc.
Gastroenterology & Urology · 85d
Cleared Apr 10, 1998
TEMPORARY CARDIAC PACING WIRE
K980503 · LDF
Ethicon, Inc.
Cardiovascular · 60d
Cleared Apr 09, 1998
SORBASTACE
K965034 · QSY
Hemostace, LLC
General & Plastic Surgery · 478d
Cleared Apr 09, 1998
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
K970761 · LSR
Cambridge Diagnostics Ireland, Ltd.
Microbiology · 402d
Cleared Apr 09, 1998
HUMAN LYME IGM WESTERN BLOT KIT
K970768 · LSR
Cambridge Diagnostics Ireland, Ltd.
Microbiology · 402d
Cleared Apr 09, 1998
ONE STEP MIDSTREAM HCG PREGNANCY TEST
K974059 · LCX
International Newtech Development, Inc.
Chemistry · 164d
Cleared Apr 09, 1998
MINISTRIP/ SERUM AND URINE COMBO HCG TEST
K974060 · JHI
International Newtech Development, Inc.
Chemistry · 164d
Cleared Apr 09, 1998
PERIACRYL
K974097 · EMA
Blacklock Medical Products, Inc.
Dental · 161d
Cleared Apr 09, 1998
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
K980079 · GCJ
Lumenis, Inc.
General & Plastic Surgery · 90d
Cleared Apr 09, 1998
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K980081 · LZO
Johnson & Johnson Professionals, Inc.
Orthopedic · 90d
Cleared Apr 09, 1998
LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60
K980091 · ITX
Cosmaceutical Marketing, Inc.
Radiology · 90d
Cleared Apr 09, 1998
ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))
K980099 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Apr 09, 1998
OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
K980159 · EMA
Closure Medical Corp.
Dental · 83d
Cleared Apr 09, 1998
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
K980235 · IZH
Kci New Technologies, Inc.
Radiology · 77d
Cleared Apr 09, 1998
BIODERM CALCIUM ALGINATE DRESSING
K980451 · KMF
Bioderm, Inc.
General & Plastic Surgery · 63d
Cleared Apr 09, 1998
KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE
K980471 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 62d