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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
136945–136968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1988
XL-4 PAGODA (CONDOMS)
K874851 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 57d
Cleared Jan 21, 1988
QUANTIMETRIX URINE DIPSTICK CONTROL
K874890 · JJW
Quantimetrix Medical Industries
Chemistry · 51d
Cleared Jan 20, 1988
IVY COMMANDER (MODEL 500)
K870820 · LDR
Ivy Medical, Inc.
General Hospital · 323d
Cleared Jan 20, 1988
LEE COMPOSITE INLAY SYSTEM
K873123 · EBF
Lee Pharmaceuticals
Dental · 163d
Cleared Jan 20, 1988
VAN DELLEN BACTERIA FILTER
K873465 · FPK
Van Dellen, Ltd.
General Hospital · 145d
Cleared Jan 20, 1988
LASER LAPAROSCOPY SET
K873598 · HET
Cuda Products Co.
Obstetrics & Gynecology · 138d
Cleared Jan 20, 1988
AGC UNICOMPARTMENTAL KNEE PROSTHESIS
K873601 · HRY
Biomet, Inc.
Orthopedic · 149d
Cleared Jan 20, 1988
ACE INTRA COMPARTMENTAL PRESSURE MONITOR
K873684 · LXC
Ace Medical Co.
Orthopedic · 128d
Cleared Jan 20, 1988
SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY
K874665 · LRP
Precision Dynamics Corp.
General & Plastic Surgery · 68d
Cleared Jan 20, 1988
VITALON MASSAGER
K874843 · ISA
Nexus Co. , Ltd. C/O Yama Trans Co. ,...
Physical Medicine · 57d
Cleared Jan 20, 1988
ACROMED CANCELLOUS BONE SCREW
K875053 · HWC
Buckman Co., Inc.
Orthopedic · 42d
Cleared Jan 20, 1988
BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1
K875103 · IKE
Shield Computers , Ltd.
Physical Medicine · 41d
Cleared Jan 20, 1988
STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM
K875156 · JDQ
Richards Medical Co., Inc.
Orthopedic · 36d
Cleared Jan 19, 1988
UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR
K870861 · CBK
Impact Instrumentation, Inc.
Anesthesiology · 322d
Cleared Jan 19, 1988
BED ALERT
K872522 · KPN
Nite Train-R Enterprises, Inc.
Gastroenterology & Urology · 208d
Cleared Jan 19, 1988
TRANSJAW(TM)
K872815 · BXB
Vitek, Inc.
Physical Medicine · 187d
Cleared Jan 19, 1988
ATTENDS INCONTINENT BRIEF
K873036 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 168d
Cleared Jan 19, 1988
EZ BRUSH & FLOSS
K873317 · EFW
Ez Products, Ltd.
Dental · 153d
Cleared Jan 19, 1988
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
K873457 · HIL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 144d
Cleared Jan 19, 1988
MEMBRANE HUMIDIFIER
K873472 · BTT
Respiratory Support Products, Inc.
Anesthesiology · 144d
Cleared Jan 19, 1988
MINI CROSSER BATTERY POWERED WHEELCHAIR
K873500 · INI
Heisteel DK Aps
Physical Medicine · 141d
Cleared Jan 19, 1988
HUCHEL BODYLINER
K873576 · IRT
Hans-Juergen Huchel
Physical Medicine · 139d
Cleared Jan 19, 1988
TRIAD NUCLEAR IMAGING SYSTEM
K873775 · KPS
Trionix Research Laboratory, Inc.
Radiology · 125d
Cleared Jan 19, 1988
SEPACELL R-500 AND SEPACELL R-500A
K873792 · CAK
Advocacy International, Ltd.
General Hospital · 124d