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
173425–173448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1977
CHEMISTRY, COULTER
K770679 · JJE
Coulter Electronics, Inc.
Chemistry · 22d
Cleared May 03, 1977
THERMOMETER, ELECTRONIC, DIGIMED HOL
K770777 · FLL
Elmed, Inc.
General Hospital · 5d
Cleared Apr 29, 1977
URIC ACID PROCEDURE, TEKPOINT DIRECT
K770459 · CDH
Icn Pharmaceuticals, Inc.
Chemistry · 52d
Cleared Apr 29, 1977
LACERATION KIT
K770479 · FMC
American Hospital Supply Corp.
General Hospital · 49d
Cleared Apr 29, 1977
SHEAR, PLASTIC HANDLE UTILITY S-475-7
K770481 · JOK
Acme United Corp.
General Hospital · 49d
Cleared Apr 29, 1977
SHEET KIT, STRETCHER, DISPOSABLE
K770486 · KME
American Hospital Supply Corp.
General Hospital · 46d
Cleared Apr 29, 1977
PATIENT TURNING AND REPOSITIONING G DEV.
K770499 · FMR
Patient Healthguards Corp.
General Hospital · 46d
Cleared Apr 29, 1977
CANNULA, INTRAVENOUS, HEPARINIZED
K770511 · FOZ
Sherwood Medical Industries
General Hospital · 43d
Cleared Apr 29, 1977
MASK, SURGICAL, DISP
K770513 · FXX
Acme Automatic Disposable
General Hospital · 43d
Cleared Apr 29, 1977
PIGGYBACK VENOSET W/0.22 FILTER
K770518 · FPA
Abbott Laboratories
General Hospital · 42d
Cleared Apr 29, 1977
NEEDLE, MEMBRANE
K770528 · FMI
American Viggo
General Hospital · 42d
Cleared Apr 29, 1977
STEAM STERILIZER, 3000
K770536 · FLE
Castle Co.
General Hospital · 39d
Cleared Apr 29, 1977
HOOK HOLLER
K770759 · KIK
Depuy, Inc.
General & Plastic Surgery · 4d
Cleared Apr 29, 1977
OTOSCOPE/ILLUMINATOR, MODEL #21100
K770769 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 1d
Cleared Apr 29, 1977
WALL CHARGER, MODEL #79111
K770770 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 1d
Cleared Apr 28, 1977
THYROSCREEN TM T4 DIAGNOSTIC KIT
K770474 · CDX
Abbott Laboratories
Immunology · 48d
Cleared Apr 28, 1977
DASP TM ANTI-RABBIT
K770597 · DEW
Organon, Inc.
Immunology · 30d
Cleared Apr 28, 1977
ELECTROSURGICAL PATIENT GROUNDING PAD
K770646 · GEI
C.R. Bard, Inc.
General & Plastic Surgery · 23d
Cleared Apr 28, 1977
FLUORESCEIN CONJUGATED ANTISERUM
K770668 · DEW
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 28, 1977
RHODAMINE-CONJUGATED ANTISERUM
K770669 · DEW
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 28, 1977
FLOR. CONJUG. HUMAN FAB FRAGMENT
K770670 · DFK
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 28, 1977
GAMBRO VENOUS BLOOD LINE
K770691 · KOC
Gambro, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 28, 1977
MONITORS, REMOTE, RMS III
K770721 · CCK
The Perkin-Elmer Corp.
Anesthesiology · 10d
Cleared Apr 28, 1977
RIA KIT, T4 CLASP
K770726 · CDX
Squibb & Sons, Inc.
Immunology · 9d