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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
117097–117120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1992
DEGUBOND PLUS
K921445 · EJS
Degussa AG
Dental · 62d
Cleared May 26, 1992
DSL DHEA (DSL 8900)
K921534 · JKL
Diagnostic Systems Laboratories, Inc.
Chemistry · 56d
Cleared May 26, 1992
BR-50-J DISPOSABLE ECG ELECTRODE
K921579 · DRX
Medicotest, Inc.
Cardiovascular · 54d
Cleared May 26, 1992
MODEL #125 CHILD STIMULATION PADS
K921606 · LDD
Cardiotronics, Inc.
Cardiovascular · 53d
Cleared May 26, 1992
BIOTROL MAGNESIUM (MAGON)
K921677 · JGJ
Biotrol, USA, Inc.
Chemistry · 48d
Cleared May 26, 1992
RIFTON MOBILE PRONE STANDERS
K921894 · IPL
Rifton Equipment For the Handicapped
Physical Medicine · 34d
Cleared May 26, 1992
THYROXINE CALIBRATOR KIT
K921903 · JIS
Tudor Laboratories, Inc.
Chemistry · 35d
Cleared May 26, 1992
DOLOMITE ROLLATOR
K921917 · INM
Seamark Technologies
Physical Medicine · 33d
Cleared May 26, 1992
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
K921998 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 33d
Cleared May 26, 1992
SHOWER CHAIRS
K922045 · INM
Medical Device Inspection Co., Inc.
Physical Medicine · 25d
Cleared May 26, 1992
CHAIR, ADJUSTABLE, MECHANICAL
K922061 · INN
Kaye Products, Inc.
Physical Medicine · 22d
Cleared May 26, 1992
SINGLE CHAIR INTEGRAL BACK ATTACHMENT
K922092 · IKK
Biodan Medical Systems, Ltd.
Physical Medicine · 21d
Cleared May 26, 1992
TAYLOR MADE MOBILE STANDER
K922107 · IPL
Nelson A. Taylor Co., Inc.
Physical Medicine · 21d
Cleared May 22, 1992
CANNULA STYLE THERMOCOUPLES
K913396 · BZG
Pro-Tech, Inc.
Anesthesiology · 297d
Cleared May 22, 1992
THE THERATEST EL-ANA PROFILES
K914454 · LKJ
Theratest Laboratories, Inc.
Immunology · 228d
Cleared May 22, 1992
3M DENTAL ELECTRONIC ANESTHESIA SYSTEM
K920119 · LWM
3M Company
Dental · 133d
Cleared May 22, 1992
AUTOSCEPTOR IDENTIFICATION SYSTEM
K920225 · LRH
Bd Becton Dickinson Vacutainer...
Microbiology · 126d
Cleared May 22, 1992
DISPOSABLE SKIN STAPLE REMOVER
K920283 · MCZ
Trinity Laboratories, Inc.
General & Plastic Surgery · 121d
Cleared May 22, 1992
LIFE LITE EMERGENCY STRETCHER
K920805 · FPP
Design Principles, Inc.
General Hospital · 91d
Cleared May 22, 1992
RICH-MAR HV 1000 MUSCLE STIMULATOR
K920833 · IPF
Rich-Mar Corp.
Physical Medicine · 87d
Cleared May 22, 1992
PRESATURATION
K920835 · LNH
Resonex, Inc.
Radiology · 88d
Cleared May 22, 1992
STERILE CONVERTOR SAFECARE GOWN AND DRAPE
K920837 · FYA
Baxter Healthcare Corp
General Hospital · 88d
Cleared May 22, 1992
BACTIDROP NINHYDRIN
K920971 · JTO
Remel Co.
Microbiology · 81d
Cleared May 22, 1992
BACTIDROP PYR
K920972 · JTO
Remel Co.
Microbiology · 81d