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
132217–132240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1989
CARRETTE 3 WHEELED MOTORIZED CART
K891609 · INI
Everest & Jennings, Inc.
Physical Medicine · 17d
Cleared Apr 05, 1989
SUPERMON ARRHYTHMIA MODULE 7270
K882206 · DSI
Kontron Instruments, Inc.
Cardiovascular · 314d
Cleared Apr 05, 1989
ENTERAL FEEDING TUBE
K890116 · FPD
Hdc Corp.
Gastroenterology & Urology · 84d
Cleared Apr 05, 1989
TELE-TEMP THERMOMETER
K890202 · FLL
Rocky Mountain Medical Corp.
General Hospital · 78d
Cleared Apr 05, 1989
SHARPLAN MODEL 750 REMOTE CONTROL UNIT (RCU)
K890286 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 76d
Cleared Apr 05, 1989
SLT CONTACT LASER SYSTEM (ORTHOPEDICS)
K890321 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 72d
Cleared Apr 05, 1989
SLT CONTACT LASER SYSTEM (ENT, HEAD & NECK SURG.)
K890322 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 72d
Cleared Apr 05, 1989
CONSUMMATE AIR THERAPY BED
K890426 · FNL
Health Products, Inc.
General Hospital · 69d
Cleared Apr 05, 1989
PATIENT EXAMINATION GLOVE
K890593 · LYY
Industri Getah Jacon
General Hospital · 58d
Cleared Apr 05, 1989
MODIFICATION HEMOFILTRATION CATHETER HF-100
K890717 · LFK
Vas-Cath, Inc.
Gastroenterology & Urology · 51d
Cleared Apr 05, 1989
FDX SOLID STATE VIDEO CAMERA MODEL 5950
K891236 · FWD
Medical Dynamics, Inc.
General & Plastic Surgery · 29d
Cleared Apr 05, 1989
NON-STERILE PATIENT EXAMINATION GLOVE
K891300 · LYY
Shun Thai Rubber Gloves Industry Co.,...
General Hospital · 23d
Cleared Apr 04, 1989
CHROMATOGRAPHY KIT
K884176 · DPA
Gelman Sciences, Inc.
Toxicology · 182d
Cleared Apr 04, 1989
SAFE MULTIPORT INJECTOR
K884511 · FPA
L & W Ent.
General Hospital · 159d
Cleared Apr 04, 1989
PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN
K890431 · GCX
Deknatel, Inc.
General Hospital · 67d
Cleared Apr 04, 1989
GIARDEIA(TM)
K890774 · KHW
Antibodies, Inc.
Microbiology · 48d
Cleared Apr 04, 1989
TROJAN FOR WOMEN
K890863 · HIS
Armkel, LLC
Obstetrics & Gynecology · 42d
Cleared Apr 04, 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873 · CGA
Heraeus Kulzer, Inc.
Chemistry · 42d
Cleared Apr 04, 1989
BUTTERFLY GLOBE (PATIENT EXAMINATION GLOVE)
K890982 · LYY
O.L. Trading, Inc.
General Hospital · 36d
Cleared Apr 04, 1989
LINISTAIN SLS
K890984 · KIO
Shandon, Inc.
Pathology · 36d
Cleared Apr 04, 1989
VINYL PATIENT EXAMINATION GLOVE
K890986 · LYZ
Precious Mountain Ent. Corp.
General Hospital · 34d
Cleared Apr 04, 1989
TOTAL BILIRUBIN FOR CONTINUOUS FLOW
K891025 · CIG
Catachem, Inc.
Chemistry · 35d
Cleared Apr 04, 1989
STERILE PATIENT EXAMINATION GLOVES
K891329 · LYY
Galaxy Intl., Inc.
General Hospital · 40d
Cleared Apr 04, 1989
NON-STERILE PATIENT EXAMINATION GLOVES
K891330 · LYY
Galaxy Intl., Inc.
General Hospital · 40d