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
132289–132312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1989
ITE HEARING AID PARKER/TECHNITONE, MODEL PA
K884997 · ESD
Hearing Enhancement Center, Inc.
Ear, Nose, Throat · 118d
Cleared Mar 29, 1989
MULTI-PURPOSE CONTROL SYSTEM
K885140 · FLE
Colliers Sterilizer Sales & Service...
General Hospital · 104d
Cleared Mar 29, 1989
AQUADERM
K885205 · KGX
Laivan Corp.
General & Plastic Surgery · 100d
Cleared Mar 29, 1989
HUNTLEIGH DYNAMIC FLOTATION SYSTEM
K890012 · FNM
Huntleigh Technology, Inc.
General Hospital · 85d
Cleared Mar 29, 1989
TOITU DOPPLER FETUS DETECTOR, FD-400D
K890139 · KNG
Toitu of America, Inc.
Obstetrics & Gynecology · 75d
Cleared Mar 29, 1989
PHOSPHORIC-ACID ETCHING GEL
K890140 · EBF
Centrix, Inc.
Dental · 75d
Cleared Mar 29, 1989
BRACE (ORAFIX SPECIAL)
K890290 · ECB
Norcliff Thayer, Inc.
Dental · 69d
Cleared Mar 29, 1989
VITAACCESS CATHETER INTRODUCER KIT
K890435 · FOZ
Vitaphore Corp.
General Hospital · 61d
Cleared Mar 29, 1989
FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS
K890494 · EBC
Macrochem Corp.
Dental · 57d
Cleared Mar 29, 1989
GELLHORN PESSARY 33410 VARIOUS SIZES
K890565 · HHW
Medi-Source, Inc.
Obstetrics & Gynecology · 51d
Cleared Mar 29, 1989
RUBBER DAM
K890667 · EIE
Cost Rite Health Products, Inc.
Dental · 48d
Cleared Mar 29, 1989
PATIENT EXAMINATION GLOVES
K890816 · LYY
Dan Co., Ltd.
General Hospital · 40d
Cleared Mar 29, 1989
ALADAN STERILE LATEX MEDICAL GLOVE
K890880 · LYY
Aladan Corp.
General Hospital · 36d
Cleared Mar 29, 1989
VINYL PATIENT EXAMINATION GLOVE
K890985 · LYZ
Am Gloves Co., Ltd.
General Hospital · 28d
Cleared Mar 29, 1989
RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE
K891011 · ESD
Resound Corp.
Ear, Nose, Throat · 29d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC
K891247 · ESF
Siemens Hearing Instruments, Inc.
General & Plastic Surgery · 21d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I
K891248 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 303 ASP
K891249 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC
K891250 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 29, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891291 · LYY
Cp Products, Inc.
General Hospital · 19d
Cleared Mar 29, 1989
AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX)
K891298 · LYY
Medi Tex, Inc.
General Hospital · 16d
Cleared Mar 29, 1989
REID ENDOCERVICAL SPREADER
K891347 · HDC
Simpson/Basye, Inc.
Obstetrics & Gynecology · 19d
Cleared Mar 29, 1989
CAMPION CERVICAL HOOK
K891349 · HDC
Simpson/Basye, Inc.
Obstetrics & Gynecology · 19d
Cleared Mar 29, 1989
NEWPORT CERVICAL MANIPULATOR
K891350 · HDC
Simpson/Basye, Inc.
Obstetrics & Gynecology · 19d