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
108145–108168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1994
MOBLVAC III
K933902 · BTA
Aeros Instruments, Inc.
General & Plastic Surgery · 283d
Cleared May 20, 1994
BACTICARD STREP
K936021 · JTO
Remel Co.
Microbiology · 154d
Cleared May 20, 1994
ELIMINATOR BALLOON DILATOR
K940965 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 79d
Cleared May 20, 1994
DERMAASSIST HYDROCOLLOID DRESSING
K941149 · FRO
Wilshire Medical Products
General & Plastic Surgery · 71d
Cleared May 20, 1994
HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING
K941216 · KMF
Wilshire Medical Products
General & Plastic Surgery · 67d
Cleared May 20, 1994
SUTURE MANIPULATOR
K941286 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 92d
Cleared May 20, 1994
STERILE GAUZE PRODUCT LINE
K941455 · EFQ
Cush Medical Products
General & Plastic Surgery · 56d
Cleared May 20, 1994
STERIVENT AND STERIVENT S
K941676 · CAH
Mallinckrodt Medical
General Hospital · 45d
Cleared May 20, 1994
LCA ANGIOGRAPHIC IMAGING SYSTEM
K941946 · IZI
GE Medical Systems
Radiology · 29d
Cleared May 20, 1994
BURN DRESSING TRAY
K942000 · FRG
Medcare Custom Packaging, Inc.
General Hospital · 25d
Cleared May 19, 1994
REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY
K930666 · GEI
Snowden-Pencer
General & Plastic Surgery · 464d
Cleared May 19, 1994
BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER
K930745 · LIT
B.Braun Medical, Inc.
Cardiovascular · 461d
Cleared May 19, 1994
ANI BIOCARD(TM) HCG TEST
K933794 · LCX
Canadian Bioclinical, Ltd.
Chemistry · 288d
Cleared May 19, 1994
CORSON AND NEZHAT SUCTION/IRRIGATION PROBES
K935786 · GCJ
Cabot Medical Corp.
General & Plastic Surgery · 164d
Cleared May 19, 1994
MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
K936247 · DRC
Medicon Instruments, Inc.
Cardiovascular · 140d
Cleared May 19, 1994
LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH
K940141 · GCJ
Micro-Medical Devices, Inc.
General & Plastic Surgery · 128d
Cleared May 19, 1994
SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS
K940709 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 91d
Cleared May 19, 1994
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · IPF
Smith & Nephew, Inc.
Physical Medicine · 73d
Cleared May 19, 1994
DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G
K941159 · JKA
International Technidyne Corp.
Chemistry · 69d
Cleared May 19, 1994
GORE SMOOTHER II AND GORE BPTB
K941269 · HRX
W.L. Gore & Associates, Inc.
Orthopedic · 64d
Cleared May 19, 1994
MICROFLOW IRRIGATION SYSTEM
K941356 · GBQ
Jedmed Instrument Co.
General & Plastic Surgery · 59d
Cleared May 19, 1994
LORREX GAUZE PADS
K941956 · EFQ
Lorons International Corp.
General & Plastic Surgery · 27d
Cleared May 19, 1994
LORREX COVER SPONGES STERILE2'S AND NON-STERILE
K942070 · EFQ
Lorrex Health Products
General & Plastic Surgery · 20d
Cleared May 19, 1994
LORREX NON-WOVEN SPONGES NON-STERILE
K942071 · EFQ
Lorrex Health Products
General & Plastic Surgery · 20d