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
106465–106488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1994
SYNERGY QUAD
K941443 · JSO
Remel Co.
Microbiology · 179d
Cleared Sep 19, 1994
BHI AGAR WITH VANCOMYCIN
K941444 · JSO
Remel Co.
Microbiology · 179d
Cleared Sep 19, 1994
IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
K942027 · JDG
Biomet, Inc.
Orthopedic · 146d
Cleared Sep 19, 1994
RX90 FEMORAL COMPONENT
K942028 · JDG
Biomet, Inc.
Orthopedic · 146d
Cleared Sep 19, 1994
SHARPS-TAINER LARGE OPENING
K942901 · FMI
Winfield Co., Inc.
General Hospital · 144d
Cleared Sep 19, 1994
SHARPS-TAINER SMALL OPENING
K942903 · FMI
Winfield Co., Inc.
General Hospital · 144d
Cleared Sep 19, 1994
MERCURY EXPIRATORY RESISTANCE EXERCISER
K942919 · BWF
Mercury Ent., Inc. D/B/A Mercury Medical
Anesthesiology · 90d
Cleared Sep 19, 1994
MEDAIR EXCEL 2000
K942920 · FNM
Medifloat, Inc.
General Hospital · 90d
Cleared Sep 19, 1994
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE
K943022 · DQX
Cardio Metrics, Inc.
Cardiovascular · 87d
Cleared Sep 19, 1994
WARMTOUCH PLASTIC WARMING COVER
K943276 · DWJ
Mallinckrodt Medical
Cardiovascular · 74d
Cleared Sep 19, 1994
CALCIUM HYDROXIDE PASTE
K943372 · EJK
Ultradent Products, Inc.
Dental · 68d
Cleared Sep 16, 1994
STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM
K924685 · IYE
Leibinger GmbH
Radiology · 730d
Cleared Sep 16, 1994
CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.
K931902 · LFL
Valleylab, Inc.
General & Plastic Surgery · 515d
Cleared Sep 16, 1994
DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM
K933454 · FRA
L&H Airco
General Hospital · 429d
Cleared Sep 16, 1994
CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX
K934987 · LNH
Elscint, Inc.
Radiology · 333d
Cleared Sep 16, 1994
MICROLINE SCREEN FOR AMPHETAMINE
K935052 · DKZ
Drug Screening Systems, Inc.
Toxicology · 331d
Cleared Sep 16, 1994
LOWER BODY CYCLES
K935061 · BXB
Biodex Medical Systems, Inc.
Physical Medicine · 330d
Cleared Sep 16, 1994
SEMI-RECUMBENT CYCLES
K935216 · BXB
Biodex Medical Systems, Inc.
Physical Medicine · 325d
Cleared Sep 16, 1994
KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID...
K935277 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 317d
Cleared Sep 16, 1994
UPPER BODY CYCLES (110 VOLT)/(220 VOLT)
K935520 · BXB
Biodex Medical Systems, Inc.
Physical Medicine · 302d
Cleared Sep 16, 1994
ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION
K935617 · HRX
Davol Inc., Sub. C. R. Bard, Inc.
Orthopedic · 298d
Cleared Sep 16, 1994
DOSER
K935955 · CAF
Newmed Corp.
Anesthesiology · 277d
Cleared Sep 16, 1994
3M 1154 LASER IMAGER
K936142 · LMC
3M Information,Imaging and Electronic...
Radiology · 263d
Cleared Sep 16, 1994
BARD URINE COLLECTION PRODUCTS MODIFICATION
K940206 · KNX
C.R. Bard, Inc.
Gastroenterology & Urology · 245d