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
97393–97416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1996
EC-384OTL, VIDEO COLONSCOPE
K961563 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 57d
Cleared Jun 19, 1996
PLAYTEX SLIMFIT TAMPONS
K961870 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 40d
Cleared Jun 18, 1996
AMBULATORY (HOLTER) RECORDING SYSTEM
K950944 · DQK
Biosensor Corp.
Cardiovascular · 487d
Cleared Jun 18, 1996
CONMED VCARE RETRACTOR/ELEVATOR
K955446 · LKF
Conmedcorp
Obstetrics & Gynecology · 202d
Cleared Jun 18, 1996
DIGISCAN 2 PLUS
K955457 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 202d
Cleared Jun 18, 1996
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
K960281 · DTB
Intermedics, Inc.
Cardiovascular · 151d
Cleared Jun 18, 1996
TITANIUM HEALING CAPS
K960634 · DZE
The Straumann Co.
Dental · 125d
Cleared Jun 18, 1996
CUSHMAN MANUFACTURING, INC. ULTRA 6.0.
K960802 · IMI
Cushman Mfg., Inc.
Physical Medicine · 112d
Cleared Jun 18, 1996
SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908
K961155 · LJS
Douglas Medical Products Corp.
General Hospital · 88d
Cleared Jun 18, 1996
HEARTPORT ENDOPULMONARY VENT
K961245 · DWF
Heartport, Inc.
Cardiovascular · 78d
Cleared Jun 18, 1996
HEARTPORT ENDOSINUS CATHETER
K961270 · DWF
Heartport, Inc.
Cardiovascular · 77d
Cleared Jun 18, 1996
SHARPLAN LASERS, INC. RUBY LASER SYSTEM
K961279 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 76d
Cleared Jun 18, 1996
DIA SCREEN 10 WAY REAGENT STRIPS
K961375 · JIL
Genesis Labs, Inc.
Chemistry · 70d
Cleared Jun 18, 1996
DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)
K961379 · JWH
Depuy, Inc.
Orthopedic · 69d
Cleared Jun 18, 1996
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
K961389 · GAW
R. K. Medical L. L. C.
General & Plastic Surgery · 69d
Cleared Jun 18, 1996
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
K961412 · JHY
Bayer Corp.
Toxicology · 67d
Cleared Jun 18, 1996
PLAYTEX TAMPONS #10296
K961456 · HIL
Playtime Products, Inc.
Obstetrics & Gynecology · 63d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 20 ANTISERUM
K961948 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 14 ANTISERUM
K961949 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM
K961950 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 6 ANTISERUM
K961951 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS
K961952 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELA H Z24 ANTISERUM
K961953 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z35 ANTISERUM
K961954 · GRM
Sa Scientific, Inc.
Microbiology · 29d