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
85513–85536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1999
STERI-PAK LF BOWIE-DICK TEST PACK
K990246 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 135d
Cleared Jun 10, 1999
AMORPHOUS DIAMOND COATED DRILL
K990846 · DZI
Nobel Biocare Uas, Inc.
Dental · 87d
Cleared Jun 10, 1999
PILLOWPOSITIVE CERVICAL PILLOW
K990871 · MYB
Lifesleep Systems, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 10, 1999
DRG TITANIUM BONE PLATE
K990920 · JEY
Doctor'S Research Group, Inc.
Dental · 84d
Cleared Jun 10, 1999
AMERICAN DENTAL PRODUCTS ETCH-DETECT
K991099 · EBC
American Dental Products, Inc.
Dental · 70d
Cleared Jun 10, 1999
`INEAR WRIST COIL, MODEL 440GE-09
K991113 · MOS
Medical Advances, Inc.
Radiology · 70d
Cleared Jun 10, 1999
VARIANT II B-THALASSEMIA
K991127 · JPD
Bio-Rad
Hematology · 69d
Cleared Jun 10, 1999
K-ASSAY MICROALBUMIN CALIBRATOR SET
K991166 · JIX
Kamiya Biomedical Co.
Chemistry · 64d
Cleared Jun 10, 1999
BROWNE MVI ETHYLENE OXIDE INDICATOR
K991418 · JOJ
Albert Browne , Ltd.
General Hospital · 48d
Cleared Jun 10, 1999
K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
K991467 · DHR
Kamiya Biomedical Co.
Immunology · 44d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT
K983839 · LSE
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
K983841 · LSE
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT, EA IGM
K983842 · LSE
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 09, 1999
FUJI CATHETER, MODEL CTH001
K983867 · KNW
Windy Hill Technology, Inc.
Gastroenterology & Urology · 219d
Cleared Jun 09, 1999
INTERSOURCE 125, MODEL 1251L
K984235 · KXK
International Brachytherapy, Inc.
Radiology · 196d
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