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
131905–131928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1989
CRYPTOSPORIDIUM CONTROL SLIDE
K890670 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 35d
Cleared Mar 16, 1989
BETA-2 MICROGLOBULIN EIA
K890694 · JZG
Serex, Inc.
Immunology · 34d
Cleared Mar 16, 1989
RIA-GNOST FERRITIN
K890697 · JMG
Cambridge Medical Technology
Immunology · 34d
Cleared Mar 16, 1989
GRAM STAIN CONTROL SLIDE
K890718 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 31d
Cleared Mar 16, 1989
EMPI REUSEABLE PIN-STYLE TENS ELECTRODE
K890747 · GXY
Empi
Neurology · 31d
Cleared Mar 16, 1989
STARTRAC
K890793 · IOL
Unisen, Inc.
Physical Medicine · 27d
Cleared Mar 16, 1989
RIA-GNOST PROGESTERONE
K890836 · JLS
Cambridge Medical Technology
Chemistry · 23d
Cleared Mar 16, 1989
EIA READER MODEL EL301
K890854 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 23d
Cleared Mar 16, 1989
ABUSCREEN FP FOR CANNABINOIDS
K890887 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Mar 16, 1989
PLAKOF
K890910 · JET
Ximex, Ltd.
Dental · 21d
Cleared Mar 16, 1989
MONO-CUBE(TM)
K890991 · KTN
Difco Laboratories, Inc.
Immunology · 17d
Cleared Mar 16, 1989
LATEX EXAMINATION GLOVES
K891065 · LYY
Modern Rubber Industrial Co., Ltd.
General Hospital · 15d
Cleared Mar 16, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
K891154 · MSJ
Atlantic Antibodies
Immunology · 10d
Cleared Mar 16, 1989
DEFEND LATEX EXAMINATION GLOVES
K891157 · LYY
Carl Parker Associates, Inc.
General Hospital · 10d
Cleared Mar 15, 1989
PG-NUMERIC(TM)
K883411 · JHF
Isolab, Inc.
Chemistry · 212d
Cleared Mar 15, 1989
LYME DISEASE IFA (IGM)
K883767 · LSR
Hillcrest Biologicals
Microbiology · 190d
Cleared Mar 15, 1989
MULTI CAMERA CONTROL UNIT (MCCU)
K884028 · JAA
Leybold-Inficon, Inc.
Radiology · 173d
Cleared Mar 15, 1989
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B
K884477 · KPR
Shimadzu Precision Instruments, Inc.
Radiology · 141d
Cleared Mar 15, 1989
VAPAMASTA 5
K884686 · CAD
Dentsply Intl.
Anesthesiology · 127d
Cleared Mar 15, 1989
B.A.C. 1000 MOBILE STANDING DEVICE
K884840 · IPL
Luconex, Inc.
Physical Medicine · 114d
Cleared Mar 15, 1989
ASTRO TRACE (MODEL AT-02)
K885137 · DSA
The LE Blanc Corp.
Cardiovascular · 90d
Cleared Mar 15, 1989
TOTAL KNEE CPM
K885182 · BXB
Invacare Corp.
Physical Medicine · 91d
Cleared Mar 15, 1989
ARROW MICRO COMPUTER CONTROL
K885212 · ITI
Invacare Corp.
Physical Medicine · 86d
Cleared Mar 15, 1989
ARROW MICRO COMPUTER CONTROL SWITCH & ENVIRON. SYS
K885261 · ITI
Invacare Corp.
Physical Medicine · 83d