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
117193–117216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1992
BRAINSCAN WORKSTATION
K915819 · HAW
Brainlab Medizinische Computersysteme...
Neurology · 133d
Cleared May 11, 1992
SUTURE REMOVAL KIT, STERILE, DISPOSABLE
K920280 · MCZ
Trinity Laboratories, Inc.
General & Plastic Surgery · 110d
Cleared May 11, 1992
DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE
K920409 · LKY
Dacomed Corp.
Gastroenterology & Urology · 101d
Cleared May 11, 1992
HIGH VAC
K920492 · DYN
Hygoplastic, Inc.
Dental · 98d
Cleared May 11, 1992
MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
K920517 · KKX
Trinity Laboratories, Inc.
General Hospital · 97d
Cleared May 11, 1992
DAB DETECTION KIT
K920600 · DEY
Ventana Medical Systems, Inc.
Immunology · 90d
Cleared May 11, 1992
SEAMLESS LATEX PATIENT EXAM GLOVES
K920700 · LYY
Digitcare Corp.
General Hospital · 90d
Cleared May 11, 1992
KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
K921055 · KNY
Kendall Healthcare Products Co....
Gastroenterology & Urology · 67d
Cleared May 11, 1992
CAMBRIDGE PC/GXT STRESS TEST SYSTEM
K921331 · DPS
Health Watch, Inc.
Cardiovascular · 53d
Cleared May 11, 1992
BIOMEDICAL HORIZONS MODEL 1001
K921369 · KNN
Biomedical Horizons, Inc.
Physical Medicine · 52d
Cleared May 11, 1992
BISCO CORE PASTE
K921439 · EBF
Bisco, Inc.
Dental · 47d
Cleared May 11, 1992
SUOENA AFFINITY (TM) MODEL #802
K921535 · KCZ
Coloplast Corp.
General & Plastic Surgery · 41d
Cleared May 08, 1992
DISINFECTION WITH THE COX DRY HEAT STERILIZER
K910925 · KMH
Cox Sterile Products, Inc.
General Hospital · 430d
Cleared May 08, 1992
DESERET(R) FLOW RESTRICTION VALVE
K914180 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 233d
Cleared May 08, 1992
RHYTHMSCAN PRECISION 6000
K914577 · DQK
Precision Health Care Systems, Inc.
Cardiovascular · 206d
Cleared May 08, 1992
ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT
K914887 · FRQ
Mallinckrodt Medical
Gastroenterology & Urology · 191d
Cleared May 08, 1992
RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET
K915109 · FPA
Ballard Medical Products
General Hospital · 177d
Cleared May 08, 1992
H WAVE MUSCLE STIMULATOR
K915230 · IPF
Electronic Waveform Laboratory, Inc.
Physical Medicine · 170d
Cleared May 08, 1992
STERILIZATION BAG, POLYESTER/WRAP
K915477 · KCT
Cgs Supplies Corp.
General & Plastic Surgery · 154d
Cleared May 08, 1992
AEC DETECTION KIT
K920566 · DEY
Ventana Medical Systems, Inc.
Immunology · 91d
Cleared May 08, 1992
180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
K920582 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 88d
Cleared May 08, 1992
DURAFUSE INFUSION PUMP
K920773 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 78d
Cleared May 08, 1992
AZITHROMYCIN, 15 MCG, SENSI DISC
K921420 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 45d
Cleared May 08, 1992
INTERFERENTIAL STIMULATOR MODEL INF 4150/A
K921441 · LIH
Biomedical Life Systems, Inc.
Neurology · 44d