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
86041–86064 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1999
NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES
K990063 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 152d
Cleared Jun 09, 1999
FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES
K990243 · GEX
Fotona D.D.
General & Plastic Surgery · 135d
Cleared Jun 09, 1999
CADISCOPE ELECTRONIC STETHOSCOPE
K990809 · DQD
Caditec AG
Cardiovascular · 90d
Cleared Jun 09, 1999
MTP UROPUMP DISPOSABLE TUBING SET
K990909 · LJH
Mtp Medical Technical Promotion GmbH
Gastroenterology & Urology · 83d
Cleared Jun 09, 1999
MTP EXTRACTION BAG
K990912 · GCJ
Mtp Medical Technical Promotion GmbH
General & Plastic Surgery · 83d
Cleared Jun 09, 1999
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
K990954 · EBW
Nsk Nakanishi, Inc.
Dental · 79d
Cleared Jun 09, 1999
VITOP DRESSING
K990974 · EFQ
Wonder & Bioenergy Hi-Tech America, Inc.
General & Plastic Surgery · 78d
Cleared Jun 09, 1999
PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/...
K991003 · FKY
Dayspring Medical, Inc.
Gastroenterology & Urology · 76d
Cleared Jun 09, 1999
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
K991077 · GZL
Microrecording Systems Consultants, LLC
Neurology · 70d
Cleared Jun 09, 1999
CAPNOCHECK II, MODEL 8400
K991086 · CCK
Bci Intl., Inc.
Anesthesiology · 70d
Cleared Jun 09, 1999
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
K991102 · DTL
Guidant Corp.
Cardiovascular · 69d
Cleared Jun 09, 1999
P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY
K991106 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Jun 09, 1999
DORNIER LASERTRODE FIBER
K991183 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 62d
Cleared Jun 09, 1999
CADD-TPN ADMINISTRATION SET, MODEL 21-7071
K991255 · FPA
Sims Deltec, Inc.
General Hospital · 57d
Cleared Jun 09, 1999
CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON...
K991301 · FPA
Sims Deltec, Inc.
General Hospital · 54d
Cleared Jun 09, 1999
K-ASSAY RHEUMATOID FACTOR
K991409 · DHR
Kamiya Biomedical Co.
Immunology · 48d
Cleared Jun 09, 1999
3402 HANDHELD PULSE OXIMETER
K991410 · DQA
Bci Intl., Inc.
Anesthesiology · 48d
Cleared Jun 09, 1999
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
K991600 · JAK
Siemens Corp.
Radiology · 30d
Cleared Jun 09, 1999
EPI-FOAM SILICONE SHEETING
K991604 · MDA
Biodermis Corp.
General & Plastic Surgery · 30d
Cleared Jun 09, 1999
GE LOGIQ 500
K991611 · IYO
General Electric Co.
Radiology · 30d
Cleared Jun 09, 1999
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K991619 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Jun 09, 1999
MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER
K991734 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 19d
Cleared Jun 09, 1999
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
K991795 · MMI
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jun 09, 1999
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796 · DDR
Diagnostic Products Corp.
Chemistry · 14d