FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127537–127560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1990
GYNECOLOGICAL INSTRUMENTATION
K895225 · HET
Gynescope Corp.
Obstetrics & Gynecology · 203d
Cleared Mar 05, 1990
IN THE EAR HEARING AID
K895368 · ESD
Hearing Crafters of America
Ear, Nose, Throat · 188d
Cleared Mar 05, 1990
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
K895449 · HGL
Ge Medical Systems Information...
Obstetrics & Gynecology · 194d
Cleared Mar 05, 1990
MD5 AUTOMATIC AUDIOMETER
K896909 · EWO
Singer Medical Products, Inc.
Ear, Nose, Throat · 84d
Cleared Mar 05, 1990
HYSTEROSCOPE
K896917 · HIH
Cabot Medical Corp.
Obstetrics & Gynecology · 84d
Cleared Mar 05, 1990
FILPOST
K896928 · ELR
Ivoclar North America, Inc.
Dental · 84d
Cleared Mar 02, 1990
COULTER CLONE T4 MONOCLONAL ANTIBODY
K893852 · GKZ
Coulter Immunology
Hematology · 281d
Cleared Mar 02, 1990
COULTER CLONE T8 MONOCLONAL ANTIBODY
K893853 · GKZ
Coulter Immunology
Hematology · 281d
Cleared Mar 02, 1990
WHITESIDE ORTHOLOC MODULAR METAL-BACKED PATELLA
K896081 · JWH
Dow Corning Wright
Orthopedic · 134d
Cleared Mar 02, 1990
SULTAN PERIO-SELECT IRRIGATION SYSTEM
K896826
Sultan Chemists, Inc.
Dental · 88d
Cleared Mar 02, 1990
IVAC MODEL 2090 INFRA RED THERMOMETER
K896914 · FLL
Y
General Hospital · 81d
Cleared Mar 02, 1990
CMW CEMENT PRESSURISATION SYSTEM
K897134 · KIH
Dentsply Intl.
Orthopedic · 65d
Cleared Mar 02, 1990
DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1
K900005 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 59d
Cleared Mar 02, 1990
APOLIPOPROTEIN B (APO B)
K900124 · DEL
Sigma Chemical Co.
Immunology · 52d
Cleared Mar 02, 1990
CONSTI-SSAGE VIBRATOR/MASSAGE
K900674 · ISA
Bio-Tech Co.
Physical Medicine · 17d
Cleared Mar 02, 1990
MOBILIMB H3 HAND CPM UNIT
K900794 · JFA
Toronto Medical Corp.
Physical Medicine · 10d
Cleared Mar 01, 1990
CLP CK/LD ISOENZYME/IMMUNO CONTROL
K896465 · JJT
Creative Laboratory Products, Inc.
Chemistry · 108d
Cleared Mar 01, 1990
F.A.S.T. TABLE
K896583 · IXR
Oec-Diasonics, Inc.
Radiology · 100d
Cleared Mar 01, 1990
SPECIMEN CONTAINER
K896794 · LIO
Westmark, Sterile Packing Systems,...
Microbiology · 90d
Cleared Mar 01, 1990
SPIROSCAN 4000
K896924 · BZG
Brentwood Instruments, Inc.
Anesthesiology · 79d
Cleared Mar 01, 1990
ENZYMUN TEST(R) TBK
K896991 · CEE
Boehringer Mannheim Corp.
Chemistry · 78d
Cleared Mar 01, 1990
UMI BRAIDED CATHETER CONNECTOR
K897128 · LYY
Universal Medical Instrument Corp.
General Hospital · 65d
Cleared Mar 01, 1990
ABBOTT COMMANDER PARALLEL PROCESSING CENTER
K897158 · JQW
Abbott Laboratories
Chemistry · 65d
Cleared Mar 01, 1990
COULTER URIC ACID REAGENT
K897161 · KNK
Coulter Electronics, Inc.
Chemistry · 63d