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
142561–142584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1986
TOTAL HEMOGLOBIN
K863104 · KHG
J. D. Assoc.
Hematology · 21d
Cleared Sep 04, 1986
IL CELLECT 7
K863290 · GKL
Instrumentation Laboratory CO
Hematology · 10d
Cleared Sep 04, 1986
IL CELLECT 8
K863291 · GKL
Instrumentation Laboratory CO
Hematology · 10d
Cleared Sep 03, 1986
MICRO PORT
K862018 · LJT
Intermedics/Infusaid, Inc.
General Hospital · 104d
Cleared Sep 03, 1986
IL SYSTEM 810, ACL AND THE REAGENT SETS
K862301 · GJA
Instrumentation Laboratory CO
Hematology · 78d
Cleared Sep 03, 1986
SENSORY 6
K862338 · HPG
Brytech, Inc.
Ophthalmic · 75d
Cleared Sep 03, 1986
HOYER DIGITAL ELECTRONIC SCALE
K862477 · FRW
Ted Hoyer & Co., Inc.
General Hospital · 65d
Cleared Sep 03, 1986
MECHANICAL INFLATION DEVICE
K862547 · DXT
American Edwards Laboratories
Cardiovascular · 62d
Cleared Sep 03, 1986
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K862630 · GSA
Medical Diagnostic Technologies, Inc.
Microbiology · 55d
Cleared Sep 03, 1986
ENZYMATIC BLOOD GLUCOSE
K862721 · CGA
U. S. Diagnostics, Inc.
Chemistry · 48d
Cleared Sep 03, 1986
TINA-QUANT(R) IGG
K862764 · DEW
Boehringer Mannheim Corp.
Immunology · 43d
Cleared Sep 03, 1986
AQUALUX LENS CASE
K862811 · HPX
Safeway Products, Inc.
Ophthalmic · 41d
Cleared Sep 03, 1986
OPM SLIT LAMP MODEL P-1 & MODEL P-3
K863048 · HJO
Optek Medico Co., Ltd.
Ophthalmic · 22d
Cleared Sep 03, 1986
BETA MEDICAL PRODUCTS EMR-301 HYDRAULIC STRETCHER
K863083 · FPO
Beta Medical Products Co.
General Hospital · 22d
Cleared Sep 03, 1986
CANNULATED LAG SCREWS
K863119 · HTY
Downs Surgical , Ltd.
Orthopedic · 20d
Cleared Sep 03, 1986
EVE COLLECTION (EYEGLASS FRAME)
K863125 · HQZ
Precision Lens Crafters
Ophthalmic · 19d
Cleared Sep 03, 1986
EYE BARRIER
K863182 · HQZ
O.R. Concepts, Inc.
Ophthalmic · 15d
Cleared Sep 03, 1986
COMPUTON(R)
K863200 · HKX
Optical Radiation Corp.
Ophthalmic · 15d
Cleared Sep 03, 1986
DEKA JR.
K863204 · LDR
Deka Research & Development Corp.
General Hospital · 15d
Cleared Sep 03, 1986
PB GRAPHICS PRINTER AND PB VIDEO DISPLAY
K863248 · CBQ
Datex Division Instrumentarium Corp.
Anesthesiology · 12d
Cleared Sep 03, 1986
CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN
K863289 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 9d
Cleared Sep 02, 1986
HA-2 HUMAN BODY COMPOSITION ANALYZER
K860749 · DSB
Dj Medical Instrument Corp. C/O...
Cardiovascular · 187d
Cleared Sep 02, 1986
OSTEONICS SHOULDER PROSTHESIS
K862535 · KWS
Osteonics Corp.
Orthopedic · 62d
Cleared Sep 02, 1986
OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE
K862550 · LIT
Meadox Surgimed, Inc.
Cardiovascular · 61d