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
107425–107448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1994
RH-806, MODEL TRANSQ
K925800 · EGJ
Iomed, Inc.
Physical Medicine · 605d
Cleared Jul 14, 1994
RH-801, MODEL TRANSQ
K925806 · EGJ
Iomed, Inc.
Physical Medicine · 605d
Cleared Jul 14, 1994
COMFORT KEYBOARD SYSTEM
K930044 · ILQ
Health Care Keyboard Co., Inc.
Physical Medicine · 555d
Cleared Jul 14, 1994
IPI DUAL LUMEN PORT
K934167 · LJT
Pudenz-Schulte Medical Research Corp.
General Hospital · 321d
Cleared Jul 14, 1994
IPI LOW PROFILE IMPORT
K934796 · LJT
Pudenz-Schulte Medical Research Corp.
General Hospital · 281d
Cleared Jul 14, 1994
AIA-PACK TT3 ASSAY
K936229 · CDP
Tosoh Medics, Inc.
Toxicology · 197d
Cleared Jul 14, 1994
CHARGED SUPOR(R) FILTER EXTENSION SET
K940980 · FPB
B. Braun of America, Inc.
General Hospital · 135d
Cleared Jul 14, 1994
STANBIO Y-GT (LIQUICOLOR) TEST SET
K941315 · JQB
Stanbio Laboratory
Chemistry · 118d
Cleared Jul 14, 1994
BIOMEK SL WITH BIOMEK SL INCUBATOR
K941498 · JQW
Beckman Analytical and Biotechnology...
Chemistry · 108d
Cleared Jul 14, 1994
BIOPSY TRAY
K941645 · FRG
Cush Medical Products
General Hospital · 101d
Cleared Jul 14, 1994
IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE
K941850 · KMK
Tnt Moborg Intl. , Ltd.
General Hospital · 91d
Cleared Jul 14, 1994
IMMOBILE STERILE AND IMMOBILE A/C STERILE
K941940 · KMK
Tnt Moborg Intl. , Ltd.
General Hospital · 84d
Cleared Jul 14, 1994
SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116
K942181 · FPA
Medtronic Minimed
General Hospital · 71d
Cleared Jul 14, 1994
AGALLOY, DISALLOY, EPSILON AND LAMBDA
K942430 · EJJ
Fen Dental Mfg., Inc.
Dental · 55d
Cleared Jul 13, 1994
PROVIDER ANNE INFUSER
K922702 · FRN
Abbott Laboratories
General Hospital · 768d
Cleared Jul 13, 1994
DEFEND SELF-SEALING STERILIZATION POUCH
K932056 · KCT
Carl Parker Associates, Inc.
General Hospital · 441d
Cleared Jul 13, 1994
THE SIGNATURE SERIES, IMC IV
K933194 · IPF
Progressive Electrical Therapeutics
Physical Medicine · 377d
Cleared Jul 13, 1994
METASYS AMALGAM SEPARATOR MST1
K934500 · EIA
Metasys Dental Products, Inc.
Dental · 302d
Cleared Jul 13, 1994
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED
K934589 · JWH
Kirschner Medical Corp.
Orthopedic · 292d
Cleared Jul 13, 1994
KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION
K935206 · JDI
Kirschner Medical Corp.
Orthopedic · 257d
Cleared Jul 13, 1994
CAP 400 AT
K935272 · CCK
Pryon Corp.
Anesthesiology · 253d
Cleared Jul 13, 1994
CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM
K935453 · MEH
U.S. Medical Products, Inc.
Orthopedic · 243d
Cleared Jul 13, 1994
PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM
K935784 · BZD
Puritan-Bennett
Anesthesiology · 219d
Cleared Jul 13, 1994
ENDOSCOPE
K935818 · GDB
Cuda Products Co.
Gastroenterology & Urology · 223d