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
136849–136872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1988
DYNATRON 2000
K880912 · IKE
Dynatronics Corp.
Physical Medicine · 12d
Cleared Mar 14, 1988
THE MICRO-VENT/HA
K873255 · DZE
Core-Vent Corp.
Dental · 210d
Cleared Mar 14, 1988
KTP/532 LASER FOR OB-GYN USE
K874837 · HHR
Laserscope
Obstetrics & Gynecology · 111d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875004 · FST
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875005 · FST
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875006 · FST
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875007 · FST
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
K875277 · LXB
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Mar 14, 1988
SANITARY MENSTRUAL NAPKIN
K875309 · HHD
Universal Health Care Products...
Obstetrics & Gynecology · 76d
Cleared Mar 14, 1988
GYNESCOPE
K880195 · HEX
Medgyn Products, Inc.
Obstetrics & Gynecology · 48d
Cleared Mar 14, 1988
MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID
K880223 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 14, 1988
WIDEX HEARING AID MODEL C1
K880273 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 52d
Cleared Mar 14, 1988
SELF GUIDING (SG) INTERLOCKING NAIL
K880737 · HSB
Orthopaedic Designs, Inc.
Orthopedic · 19d
Cleared Mar 14, 1988
BUSHLINE CARE CHAIR
K880786 · INO
Bushline Corp.
Physical Medicine · 17d
Cleared Mar 14, 1988
GOLDEN POWER LIFT CHAIR
K880800 · INO
Golden Technologies, Inc.
Physical Medicine · 14d
Cleared Mar 14, 1988
MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM
K880826 · KYK
Johnson & Johnson Professionals, Inc.
Orthopedic · 13d
Cleared Mar 14, 1988
URESIL WOUND DRAIN TROCAR
K880895 · GBS
Uresil Corp.
General & Plastic Surgery · 12d
Cleared Mar 14, 1988
MECHANICAL WALKER
K880986 · INM
Canhart Industries, Inc.
Physical Medicine · 6d
Cleared Mar 11, 1988
PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.
K873150 · HFM
Pediatric Diagnostic Service
Obstetrics & Gynecology · 213d
Cleared Mar 11, 1988
RNP ANTIBODY TEST KIT
K874152 · LKO
Lipogen, Inc.
Immunology · 150d
Cleared Mar 11, 1988
LA ANTIBODY TEST KIT
K874195 · LJM
Lipogen, Inc.
Immunology · 149d
Cleared Mar 11, 1988
ENVICLUSIVE (TM)
K874554 · NAD
Marion Laboratories, Inc.
General & Plastic Surgery · 128d
Cleared Mar 11, 1988
HEALTHPHONE TOCO MODEL
K874631 · HFM
Carelink
Obstetrics & Gynecology · 122d
Cleared Mar 11, 1988
OBT STEREOTACTIC SYSTEM
K874693 · HAW
Tipal Instruments , Ltd.
Neurology · 127d