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
85369–85392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1999
QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
K990325 · DKZ
Syntron Bioresearch, Inc.
Toxicology · 142d
Cleared Jun 24, 1999
MTM BIOSCANNER C TEST STRIPS
K990688 · CHH
Polymer Technology Systems, Inc.
Chemistry · 119d
Cleared Jun 24, 1999
SIEMENS INFINITY EEG POD
K991012 · OLT
Siemens Medical Solutions USA, Inc.
Neurology · 90d
Cleared Jun 24, 1999
QUANTEC-E IRRIGATION SYSTEM
K991035 · EIA
Sybron Dental Specialties, Inc.
Dental · 87d
Cleared Jun 24, 1999
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
K991653 · FPA
Rymed Technologies, Inc.
General Hospital · 42d
Cleared Jun 24, 1999
LATEX EXAMINATION GLOVES (POWDER FREE)
K991689 · LYY
Usg Healthguard Sdn Bhd
General Hospital · 37d
Cleared Jun 24, 1999
LATEX EXAMINATION GLOVES (PRE POWDERED)
K991690 · LYY
Usg Healthguard Sdn Bhd
General Hospital · 37d
Cleared Jun 24, 1999
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
K991775 · DXG
Mennen Medical, Inc.
Cardiovascular · 30d
Cleared Jun 24, 1999
RENEW LEAD EXTENSION
K991784 · GZB
Advanced Neuromodulation Systems
Neurology · 30d
Cleared Jun 24, 1999
CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15
K991891 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 21d
Cleared Jun 23, 1999
SARGON IMMEDIATE LOAD IMPLANT, MODEL D
K981141 · DZE
Sargon Ent., Inc.
Dental · 450d
Cleared Jun 23, 1999
CAPIOX CARDIOPLEGIA
K982467 · DTR
Terumo Medical Corp.
Cardiovascular · 343d
Cleared Jun 23, 1999
Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
K984298 · HAW
Z-Kat, Inc.
Neurology · 203d
Cleared Jun 23, 1999
LONGPORT MODEL LDS -1
K990238 · IYO
Longport, Inc.
Radiology · 149d
Cleared Jun 23, 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
K990876 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 99d
Cleared Jun 23, 1999
SYNTHES QUICK LOCK IMF SYSTEM
K991004 · DYX
Synthes (Usa)
Dental · 90d
Cleared Jun 23, 1999
RC BUTTRESS
K991009 · MAI
Biomet, Inc.
Orthopedic · 89d
Cleared Jun 23, 1999
ORASCOPE
K991011 · EIA
Fiberdent Corp.
Dental · 89d
Cleared Jun 23, 1999
MINIMED 407C INFUSION PUMP, MODEL 407C
K991013 · FRN
Medtronic Minimed
General Hospital · 89d
Cleared Jun 23, 1999
SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC,...
K991021 · ELC
Nsk Nakanishi, Inc.
Dental · 86d
Cleared Jun 23, 1999
ACTIWATCH-SCORE
K991033 · GWQ
Mini-Mitter Co., Inc.
Neurology · 86d
Cleared Jun 23, 1999
EUCLID REDUCTION AND GUIDANCE SYSTEM
K991037 · JDS
Modular Cutting Systems, Inc.
Orthopedic · 86d
Cleared Jun 23, 1999
METACARPAL FIXATION SYSTEM
K991064 · HTY
Medcanica, Inc.
Orthopedic · 84d
Cleared Jun 23, 1999
CELL-DYN 1200 SYSTEM
K991142 · GKZ
Abbott Laboratories
Hematology · 79d