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
143497–143520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1986
THREADED TITANIUM METAL BACKED ACETABULAR CUP
K861400 · LZO
Depuy, Inc.
Orthopedic · 63d
Cleared Jun 17, 1986
RESUSIKIT
K861482 · CAE
Begley Enterprises, Inc.
Anesthesiology · 56d
Cleared Jun 17, 1986
DELFIA (TM) HUMAN PROLACTIN
K861542 · CFT
Lkb Instruments, Inc.
Chemistry · 54d
Cleared Jun 17, 1986
ACUSON S328, L382, L538 & L312 TRANSDUCERS
K861578 · HGL
Acuson Computed Sonography
Obstetrics & Gynecology · 50d
Cleared Jun 17, 1986
GRAM NEGATIVE COMBO PANEL TYPE 3
K861584 · JWY
American Micro Scan
Microbiology · 49d
Cleared Jun 17, 1986
WECK INSTRUMENT CLEANER, CAT. NO. 850-103
K861588 · FLG
Palmetto Chemical & Supply Co., Inc.
General Hospital · 49d
Cleared Jun 17, 1986
WEC-KLEEN, CATALOG N. 850-102
K861590 · FLG
Palmetto Chemical & Supply Co., Inc.
General Hospital · 49d
Cleared Jun 17, 1986
WEC-WASH, CATALOG NO. 850-115
K861592 · FLG
Palmetto Chemical & Supply Co., Inc.
General Hospital · 49d
Cleared Jun 17, 1986
VISION TOTAL PROTEIN
K861798 · CEK
Abbott Laboratories
Chemistry · 39d
Cleared Jun 17, 1986
WAXTREAT B
K861800
Beaute Naturelle International, Inc.
General & Plastic Surgery · 39d
Cleared Jun 17, 1986
WAXTREAT F
K861801
Beaute Naturelle International, Inc.
General & Plastic Surgery · 39d
Cleared Jun 17, 1986
MULTI-4 CO-OXIMETER CONTROL
K861901 · JJY
Allied Instrumentation Laboratory
Chemistry · 32d
Cleared Jun 17, 1986
CHILDREN'S SUNGLASSES
K861927 · HQY
Jestroy, Ltd.
Ophthalmic · 29d
Cleared Jun 17, 1986
SOFT LENS FOLDER
K861990 · KYB
Staar Surgical Co.
Ophthalmic · 25d
Cleared Jun 17, 1986
ZEISS 30 SL-L
K862004 · HJO
Carl Zeiss, Inc.
Ophthalmic · 21d
Cleared Jun 17, 1986
SPIROMATE AS-600
K862023 · BZG
Riko Medical & Scientific Instrument...
Anesthesiology · 20d
Cleared Jun 17, 1986
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
K862037 · DXY
Medtronic Vascular
Cardiovascular · 20d
Cleared Jun 17, 1986
MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER
K862038 · DXY
Medtronic Vascular
Cardiovascular · 20d
Cleared Jun 17, 1986
WM10, WM20, WM30 POWER MASSAGER
K862041 · ISA
Associated Mills, Inc.
Physical Medicine · 20d
Cleared Jun 17, 1986
INTER-SHARP
K862070 · HNW
Intermedics Intraocular, Inc.
Ophthalmic · 18d
Cleared Jun 17, 1986
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN
K862071 · DXY
Medtronic Vascular
Cardiovascular · 18d
Cleared Jun 17, 1986
FACE TANNER
K862097 · FTC
Tan America Mfg.
General & Plastic Surgery · 15d
Cleared Jun 17, 1986
VISION ALBUMIN
K862138 · CJW
Abbott Laboratories
Chemistry · 13d
Cleared Jun 17, 1986
SUN-DREAMER SUNTANNING BED
K862142 · FTC
Sun-Dream Tanning , Ltd.
General & Plastic Surgery · 13d