Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
148753–148776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1985
COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY
K851942 · JJY
Coulter Electronics, Inc.
Chemistry · 28d
Cleared May 31, 1985
ENDAB TSH
K851980 · JLW
Immunotech Corp.
Chemistry · 24d
Cleared May 31, 1985
LD-L REAGENT
K851996 · CFJ
Alpkem Corp.
Chemistry · 24d
Cleared May 31, 1985
IP ACID REAGENT IP MOLY BDATE REAGENT
K852003 · CEO
Alpkem Corp.
Chemistry · 24d
Cleared May 31, 1985
SC-360 SPECTROPHOTOMETER
K852047 · JJQ
Pharmacia, Inc.
Chemistry · 22d
Cleared May 31, 1985
DIRECT BILIRUBEN CALIBRATIONS
K852067 · JIT
Data Medical Associates, Inc.
Chemistry · 21d
Cleared May 31, 1985
TOTAL BILIRUBIN STANDARDS
K852068 · JIS
Data Medical Associates, Inc.
Chemistry · 21d
Cleared May 31, 1985
INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN
K852103 · CEO
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared May 31, 1985
PORTASUN MODEL 600/LI SUNLAMP
K852149 · FTC
Portasun , Ltd.
General & Plastic Surgery · 14d
Cleared May 30, 1985
BORNING NEONATAL RESUSCITATOIN CENTER
K850069 · FMT
Borning Corp.
General Hospital · 147d
Cleared May 30, 1985
SPECTACLE FRAME
K851130 · HQZ
New Brillette A/S
Ophthalmic · 70d
Cleared May 30, 1985
SUNGLASES
K851163 · HQG
Full See Glasses Ind. Co., Ltd.
Ophthalmic · 69d
Cleared May 30, 1985
IV/0165 INFUSION SET
K851336 · FPA
Infarkem Corp.
General Hospital · 57d
Cleared May 30, 1985
ENTERAL FEEDING PUMP
K851351 · FRN
Empire Industries, Inc.
General Hospital · 56d
Cleared May 30, 1985
ANESTHESIOMETER
K851557 · HJC
Luneau SA
Ophthalmic · 44d
Cleared May 30, 1985
MODEL 2000 INDULIN INFUSION PUMP
K851564 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 44d
Cleared May 30, 1985
SOLEX & SAXON INT'L OPTICAL OF HONG KONG
K851661 · HQZ
South West Intl., Inc.
Ophthalmic · 37d
Cleared May 30, 1985
37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS
K851791 · HNR
Artiberia
Ophthalmic · 35d
Cleared May 30, 1985
37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS
K851792 · HNR
Artiberia
Ophthalmic · 35d
Cleared May 30, 1985
ON TARGET
K851887 · HPX
Newman Assoc.
Ophthalmic · 29d
Cleared May 30, 1985
CRE BUFFER CRE DYE
K851993 · CGX
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
ALT (ALANINE AMINO-THRANSFERASE)REAGENT
K851995 · CKA
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
LD-P REAGENT
K851997 · CFJ
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
ALP(ALKALINE)(PHOSPHATASE) REAGENT
K851998 · CJE
Alpkem Corp.
Chemistry · 23d