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
127729–127752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 1990
MENNEN BONE FIXATION DEVICE
K892411 · JDQ
Dentsply Intl.
Orthopedic · 273d
Cleared Jan 05, 1990
WHITESIDE ORTHOLOC MODULAR-C TOTAL KNEE SYSTEM
K896045 · JWH
Dow Corning Wright
Orthopedic · 80d
Cleared Jan 04, 1990
LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET
K890192 · KWP
Danek Medical, Inc.
Orthopedic · 351d
Cleared Jan 04, 1990
ITC PRESCRIPTION SERIES MODEL CA AND C
K891914 · ESD
Us Hearing Centers, Inc.
Ear, Nose, Throat · 283d
Cleared Jan 04, 1990
BIO-STYM 250 (MUSCLE STIMULATOR)
K891987 · IPF
Electronic Health Technologies, Inc.
Physical Medicine · 282d
Cleared Jan 04, 1990
DISPOSABLE NEEDLE, ASPIRATION AND INJECTION
K893233 · FMF
Pioneer Intl. Co.
General Hospital · 251d
Cleared Jan 04, 1990
MODEL 5070
K894855 · LNH
Medical Advances, Inc.
Radiology · 157d
Cleared Jan 04, 1990
K-2 TENS OR MED TENS
K894964 · GZJ
Oms Medical Supplies, Inc.
Neurology · 139d
Cleared Jan 04, 1990
INTRAMEDULLARY HIP SCREW
K895241 · KTT
Richards Medical Co., Inc.
Orthopedic · 136d
Cleared Jan 04, 1990
AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC
K895517 · ESD
Aural Technologies, Inc.
Ear, Nose, Throat · 114d
Cleared Jan 04, 1990
CROSS MEDICAL PRODUCT PEDICLE AWL
K895587 · HWJ
Cross Medical Products, Inc.
Orthopedic · 111d
Cleared Jan 04, 1990
ITE HEARING AID MODEL PA
K895590 · ESD
Best Aid, Inc.
Ear, Nose, Throat · 111d
Cleared Jan 04, 1990
MOBILIMB J1 TMJ CPM UNIT
K895720 · BXB
Toronto Medical Corp.
Physical Medicine · 101d
Cleared Jan 04, 1990
IVT 0.014 GUIDE WIRE
K895903 · DQX
Intensive Technology, Inc.
Cardiovascular · 90d
Cleared Jan 04, 1990
PSG(TM) EDM(TM) INFUSION CATHETER
K895932 · DQY
Peripheral Systems Group
Cardiovascular · 86d
Cleared Jan 04, 1990
ICOR CMU Q PLUS
K895935 · BZL
Icor AB
Anesthesiology · 85d
Cleared Jan 04, 1990
MODEL MC6500 ELECTROCARDIOGRAPH
K895961 · DSH
Cambridge Medical Instruments, Inc.
Cardiovascular · 86d
Cleared Jan 04, 1990
OHMEDA 9000 SYRINGE PUMP
K896023 · FRN
Ohmeda Medical
General Hospital · 79d
Cleared Jan 04, 1990
WALLACH CC/BRUSH
K896065 · HHT
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 78d
Cleared Jan 04, 1990
L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)
K896076 · LZC
Advance Medical Designs, Inc.
General Hospital · 77d
Cleared Jan 04, 1990
KINEMAX TIBIAL STEM EXTENSION
K896452 · JWH
Howmedica Corp.
Orthopedic · 56d
Cleared Jan 04, 1990
KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG)
K896605 · GAA
National-Standard Medical Products
General & Plastic Surgery · 44d
Cleared Jan 04, 1990
JACKSON FINE NEEDLE ASPIRATION SYSTEM
K896606 · GAA
National-Standard Medical Products
General & Plastic Surgery · 44d
Cleared Jan 04, 1990
CINE CAMERA CONTROL MODEL PK2037
K896615 · IZJ
Perkins Mfg. Co.
Radiology · 44d