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
131761–131784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT ALP
K890521 · CJE
Abbott Laboratories
Chemistry · 50d
Cleared Mar 24, 1989
KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT
K890573 · JIY
Kenlor Industries, Inc.
Chemistry · 46d
Cleared Mar 24, 1989
O-020 LASER INDIRECT OPHTHALMOSCOPE
K890787 · HGF
Hgm Medical Laser Systems, Inc.
Obstetrics & Gynecology · 37d
Cleared Mar 24, 1989
HEXASCAN SCANNER HANDPIECE
K890865 · GEX
Metatech Corp.
General & Plastic Surgery · 31d
Cleared Mar 24, 1989
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
K890908 · KHO
Baxter Healthcare Corp
Chemistry · 29d
Cleared Mar 24, 1989
TEXMED LATEX EXAMINATION GLOVE
K891120 · LYY
Transcorp
General Hospital · 22d
Cleared Mar 24, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891424 · LYY
Oon Corp. Resources
General Hospital · 10d
Cleared Mar 24, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891434 · LYY
Sime Darby USA
General Hospital · 9d
Cleared Mar 23, 1989
POLYMER ADHESIVE BANDAGE
K883391 · NAD
Marion Laboratories, Inc.
General & Plastic Surgery · 226d
Cleared Mar 23, 1989
TURBO AIR COMPRESSOR 8000
K883829 · BTI
Necon Medical, Inc.
Anesthesiology · 195d
Cleared Mar 23, 1989
MODEL ESP-200 MAMMOGRAPHIC SYSTEM
K884345 · IZH
Acoma Medical Imaging, Inc.
Radiology · 160d
Cleared Mar 23, 1989
BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR
K884849 · HCC
Moe
Neurology · 125d
Cleared Mar 23, 1989
IMS-3 PICTURE ARCHIVING SYSTEM
K884990 · LMB
The Biomedical Engineering Center
Radiology · 112d
Cleared Mar 23, 1989
DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A
K885316 · KXO
Hewlett-Packard Co.
Obstetrics & Gynecology · 84d
Cleared Mar 23, 1989
CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP
K890062 · FRN
Pharmacia Deltec, Inc.
General Hospital · 73d
Cleared Mar 23, 1989
RICH-MAR CONDUCTIVE GEL II W/ALOE VERA
K890147 · IPF
Rich-Mar Corp.
Physical Medicine · 69d
Cleared Mar 23, 1989
TECHNOMED PULSOLITH LASER SYSTEM
K890436 · FFK
Teknomed, Inc.
Gastroenterology & Urology · 55d
Cleared Mar 23, 1989
PTI - LATEX EXAMINATION GLOVES
K890456 · LYY
Precision Trading Intl., Inc.
General Hospital · 52d
Cleared Mar 23, 1989
NU-DERM HYDROCOLLOID DRESSING
K890545 · FRO
Johnson & Johnson Patient Care, Inc.
General & Plastic Surgery · 48d
Cleared Mar 23, 1989
STANDING DANI WHEELSTAND
K890602 · IPL
Davis Positioning Systems, Inc.
Physical Medicine · 45d
Cleared Mar 23, 1989
UNSTERILE PATIENT EXAMINATION GLOVE
K890627 · LYY
Aladan Corp.
General Hospital · 43d
Cleared Mar 23, 1989
NE-CHECK
K890767 · JPK
Streck Laboratories, Inc.
Hematology · 36d
Cleared Mar 23, 1989
REHABOT-YM
K890838 · BXB
Imex Health, Inc.
Physical Medicine · 30d
Cleared Mar 23, 1989
LATEX EXAMINATION GLOVES
K890847 · LYY
Prime Merit Intl. Corp.
General Hospital · 30d