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
100561–100584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1995
LD GENERAL PURPOSE DISINFECTANT
K952929 · LRJ
Alcide Corp.
General Hospital · 110d
Cleared Oct 07, 1995
MODEL 1100 MEDMATE INFUSION PUMP
K953270 · FRN
Patient Solutions, Inc.
General Hospital · 86d
Cleared Oct 07, 1995
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
K953290 · KZD
Olympus America, Inc.
General Hospital · 85d
Cleared Oct 07, 1995
MS CLASSIQUE BALLOON DILATATION CAHTETER
K953332 · FGE
Meadox Medicals, Div. Boston...
Gastroenterology & Urology · 82d
Cleared Oct 07, 1995
ELECTROCAUTERY SHROUD
K953418 · GCJ
I.C Medical, Inc.
General & Plastic Surgery · 85d
Cleared Oct 07, 1995
FOX FASTIDIOUS TEST PANELS
K953422 · JWY
Micro-Media Systems, Inc.
Microbiology · 92d
Cleared Oct 07, 1995
CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING
K953475 · LMC
The DU Pont Co.
Radiology · 75d
Cleared Oct 07, 1995
MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING
K953477 · LMC
The DU Pont Co.
Radiology · 75d
Cleared Oct 07, 1995
COURIER II
K953514 · LMD
Gammex, Inc.
Radiology · 73d
Cleared Oct 07, 1995
ICU STOPCOK WITH EXTENSION TUBING
K953573 · FMG
Icu Medical, Inc.
General Hospital · 68d
Cleared Oct 07, 1995
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER
K953597 · EZN
Meadox Medicals, Div. Boston...
Gastroenterology & Urology · 67d
Cleared Oct 07, 1995
UNITRON MODEL IKON AOHPD
K953727 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 58d
Cleared Oct 07, 1995
TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L...
K953888 · EOB
Vista Medical Technologies, Inc.
Ear, Nose, Throat · 51d
Cleared Oct 07, 1995
DENTAL ULTRASONIC SCALER INSERTS
K953919 · ELC
Hu-Friedy Mfg. Co., Inc.
Dental · 47d
Cleared Oct 07, 1995
UNITRON MODEL SOUND F/XD
K953932 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 61d
Cleared Oct 07, 1995
AALTO SCIENTIFIC LIQUID CARDIAC CONTROL
K954074 · JJY
Aalto Scientific, Ltd.
Chemistry · 38d
Cleared Oct 07, 1995
CYTOLOGY BRUSH
K954121 · FDX
Lighthouse Medical, Inc.
Gastroenterology & Urology · 36d
Cleared Oct 07, 1995
PHILIPS TOMOSCAN SR 8000
K954255 · JAK
Philips Medical Systems North...
Radiology · 26d
Cleared Oct 07, 1995
ACTIVE THYROXINE RIA
K954312 · CDX
Diagnostic Systems Laboratories, Inc.
Chemistry · 22d
Cleared Oct 07, 1995
COMPAX 90/15E
K954356 · IXR
General Electric Co.
Radiology · 19d
Cleared Oct 07, 1995
ARGENDENT GIO 86 FR
K954358 · EJT
Argen Precious Metals, Inc.
Dental · 19d
Cleared Oct 07, 1995
SILFREE 80SF+
K954359 · EJT
Argen Precious Metals, Inc.
Dental · 19d
Cleared Oct 07, 1995
ARGESOL 600
K954360 · EJT
Argen Precious Metals, Inc.
Dental · 19d
Cleared Oct 07, 1995
ARGENCO 68M
K954361 · EJT
Argen Precious Metals, Inc.
Dental · 19d