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
129841–129864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1989
VINYL EXAMINATION GLOVES (NON-STERILE)
K894025 · LYZ
Good Glove Corp.
General Hospital · 97d
Cleared Sep 11, 1989
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
K894124 · HWC
Osteonics Corp.
Orthopedic · 91d
Cleared Sep 11, 1989
STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE
K894398 · FRC
Pymah Corp.
General Hospital · 56d
Cleared Sep 11, 1989
STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.
K894399 · FRC
Pymah Corp.
General Hospital · 56d
Cleared Sep 11, 1989
DISPOSABLE IV INDUCTION COVER
K894427 · FMK
Central Plastic, Inc.
General & Plastic Surgery · 56d
Cleared Sep 11, 1989
PERSONAL BACK WITH FIP KIT
K894770 · KNN
Canadian Posture and Seating Centre,...
Physical Medicine · 47d
Cleared Sep 11, 1989
SURGI SQUEEZ
K894927 · KZD
Ethox Corp.
General Hospital · 40d
Cleared Sep 11, 1989
MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE
K895010 · HLI
Mentor O & O, Inc.
Ophthalmic · 34d
Cleared Sep 11, 1989
ARTROMOT(TM) CPM DEVICES
K895015 · BXB
Buckman Co., Inc.
Physical Medicine · 34d
Cleared Sep 11, 1989
MODEL #510/515 GENERAL TRANSPORT STRETCHER
K895016 · INW
Midmark Corp.
Physical Medicine · 34d
Cleared Sep 11, 1989
ACE ORTHOPAEDIC WASHERS
K895107 · HTN
Buckman Co., Inc.
Orthopedic · 27d
Cleared Sep 11, 1989
INTERMEDICS POWER BROACH IMPACTOR
K895121 · HSZ
Intermedics Orthopedics
Orthopedic · 27d
Cleared Sep 11, 1989
ZIGGY MEDICHAIR
K895165 · INM
Laszlo Corp.
Physical Medicine · 20d
Cleared Sep 08, 1989
ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID
K875317 · IPF
Electro Therapeutic Devices, Inc.
Physical Medicine · 619d
Cleared Sep 08, 1989
ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
K884709 · ODD
Primrose Medical, Inc.
Gastroenterology & Urology · 304d
Cleared Sep 08, 1989
ESOPHAGEAL AND PYLORIC BALLOON DIALATORS
K884712 · KNQ
Primrose Medical, Inc.
Gastroenterology & Urology · 304d
Cleared Sep 08, 1989
RUBENSTEIN URETERAL STONE FRAGMENT BRUSH
K885168 · FGO
Boston Scientific Corp
Gastroenterology & Urology · 269d
Cleared Sep 08, 1989
STERILE NATURAL LATEX SURGICAL GLOVES
K892108 · KGO
Ruhn Chang Industrial Co., Ltd.
General Hospital · 158d
Cleared Sep 08, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K892191 · LYZ
Hsing YI Plastics Processing Co, Ltd.
General Hospital · 156d
Cleared Sep 08, 1989
PATIENT EXAMINATION GLOVES
K893050 · LYY
Paratex Product Co., Ltd.
General Hospital · 148d
Cleared Sep 08, 1989
LATEX EXAMINATION GLOVES
K893263 · LYY
Regent Group Co., Ltd.
General Hospital · 144d
Cleared Sep 08, 1989
BIPOLAR ELECTROSURGICAL SNARE
K893553 · FDI
Everest Medical Corp.
Gastroenterology & Urology · 123d
Cleared Sep 08, 1989
LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
K893721 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 08, 1989
LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT
K893722 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 114d