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
134881–134904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 1988
HYPODERMIC NEEDLE SHEATH HOLDER
K882405 · FMJ
Ansr Ent., Inc.
General Hospital · 19d
Cleared Jun 28, 1988
RIGEL MODEL MULTICARE 409
K875160 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 196d
Cleared Jun 28, 1988
ULTRAVIOLET LIGHT PROTECTVE EYEWERE
K880666 · HOY
Free Sun Intl. AB
Ophthalmic · 131d
Cleared Jun 28, 1988
SLC HARD LENS CLEANER
K880688 · LPN
Ocular Pharmaceuticals, Inc.
Ophthalmic · 127d
Cleared Jun 28, 1988
OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL
K881091 · ELW
Coe Laboratories, Inc.
Dental · 112d
Cleared Jun 28, 1988
MSI 3002 SERIES BED
K881963 · FNL
Med Service, Inc.
General Hospital · 49d
Cleared Jun 28, 1988
MSI 3003 SERIES BED
K881964 · FNJ
Med Service, Inc.
General Hospital · 49d
Cleared Jun 28, 1988
RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE
K881980 · FMF
Habley Medical Technology Corp.
General Hospital · 47d
Cleared Jun 28, 1988
HR-1000 W/SUFFIXES (B,C OR D)
K882184 · LMB
Eigen
Radiology · 35d
Cleared Jun 28, 1988
NEPHROSS I.Q. ALLEGO
K882213 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 33d
Cleared Jun 28, 1988
NEPHROSS I.Q. MODERATO
K882215 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 33d
Cleared Jun 28, 1988
HI FLOW 50
K882328 · BYJ
Minnesota Valley Engineering, Inc.
Anesthesiology · 22d
Cleared Jun 28, 1988
BIO*NEPHROSS I.Q. ANDANTE
K882339 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 22d
Cleared Jun 28, 1988
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
K882351 · JTZ
Lakewood Biochemical Co., Inc.
Microbiology · 21d
Cleared Jun 28, 1988
HOOD TRACHEAL STOMA BUTTON
K882430 · BTO
Hood Laboratories
Anesthesiology · 14d
Cleared Jun 28, 1988
JAYCO HYDROGEN MONITOR
K882499 · NRH
Enteron, Inc.
Chemistry · 11d
Cleared Jun 27, 1988
NEW JELLIACOAT
K880189 · HIS
K&G Import/Export Co.
Obstetrics & Gynecology · 159d
Cleared Jun 27, 1988
SURGICAL GARMENTS
K880484 · FYC
Greene International Corp.
General Hospital · 144d
Cleared Jun 27, 1988
PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM
K881358 · HOX
Neuroscientific Corp.
Ophthalmic · 88d
Cleared Jun 27, 1988
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
K881367 · JPA
Instrumentation Laboratory CO
Hematology · 88d
Cleared Jun 27, 1988
DIDECO-SHILEY AUTOTRANS BT 795/AA
K881683 · CAC
Shiley, Inc.
Anesthesiology · 69d
Cleared Jun 27, 1988
KTP/532(TM) SURGICAL LASER
K881788 · GEX
Laserscope
General & Plastic Surgery · 62d
Cleared Jun 27, 1988
3M WOUND CONTACT MATERIAL, PRODUCT #563X
K881988 · NAD
3M Company
General & Plastic Surgery · 46d
Cleared Jun 27, 1988
STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT
K882253 · KNN
Stoute'S "Assist-Seat" Corp.
Physical Medicine · 27d