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
128329–128352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 04, 1990
EQUIP COVERS, STERILE
K897120 · KKX
Amedic USA
General Hospital · 9d
Cleared Jan 03, 1990
ELT OR ERGONOMIC LIFT TRAINER
K890500 · HCC
Physical Health Devices, Inc.
Neurology · 336d
Cleared Jan 03, 1990
PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.
K893622 · CBK
Preemicare Corp.
Anesthesiology · 237d
Cleared Jan 03, 1990
SILASTIC SOFT SHEETING
K894226 · FRO
Dow Corning Wright
General & Plastic Surgery · 198d
Cleared Jan 03, 1990
RENNER-PLAN
K894722 · IYE
W.D. Renner Consulting Co.
Radiology · 162d
Cleared Jan 03, 1990
ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
K895417 · LFJ
Arrow Intl., Inc.
Gastroenterology & Urology · 124d
Cleared Jan 03, 1990
GYN-PROBE
K895774 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 99d
Cleared Jan 03, 1990
OPTILASE YAG MODEL 1000
K895874 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 91d
Cleared Jan 03, 1990
MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.
K896019 · GAA
Dlp, Inc.
General & Plastic Surgery · 79d
Cleared Jan 03, 1990
MEDISONIC PNEU-NEB
K896192 · CAF
Medisonic U.S.A., Inc.
Anesthesiology · 70d