FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
136129–136152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1988
DIRECT BILIRUBIN PROCEDURE
K881166 · CIG
Data Medical Associates, Inc.
Chemistry · 41d
Cleared Apr 28, 1988
IRON PROCEDURE
K881167 · JIY
Data Medical Associates, Inc.
Chemistry · 41d
Cleared Apr 28, 1988
CARBON DIOXIDE REAGENT
K881169 · KHS
Intersect Systems, Inc.
Chemistry · 41d
Cleared Apr 28, 1988
PHOSPHORUS (INORGANIC)
K881171 · CEO
Tech-Co, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
CHLORIDE LIQUID STABLE REAGENT SET
K881200 · CHJ
Medical Analysis Systems, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
IRON TEST
K881202 · JIY
Sclavo, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
ACP KINETIC TEST (ACID PHOSPHATASE TEST)
K881204 · CKB
Sclavo, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
CREATINE KINASE (CK) REAGENT SET
K881237 · JHX
Tech-Neal Scientific, Inc.
Chemistry · 37d
Cleared Apr 28, 1988
CHLORIDE REAGENT SET
K881240 · CHJ
Tech-Neal Scientific, Inc.
Chemistry · 37d
Cleared Apr 28, 1988
DUODERM(R) HYDROACTIVE(R) PASTE
K881302 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 31d
Cleared Apr 28, 1988
BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K881311 · JQB
Biotrol, USA, Inc.
Chemistry · 31d
Cleared Apr 28, 1988
GAUZE AND LAP SPONGES -STERILE & NON-STERILE
K881395 · EFQ
A Plus International, Inc.
General & Plastic Surgery · 24d
Cleared Apr 28, 1988
CREATININE FOR CONTINUOUS FLOW INSTRUMENTS
K881400 · CGX
Catachem, Inc.
Chemistry · 24d
Cleared Apr 28, 1988
MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM
K881439 · JXA
Los Alamos Diagnostics
Microbiology · 23d
Cleared Apr 27, 1988
BIO-EMG MODEL 800
K873947 · KZM
Bio-Research Associates, Inc.
Dental · 212d
Cleared Apr 27, 1988
MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
K874084 · FKQ
National Medical Care, Medical...
Gastroenterology & Urology · 203d
Cleared Apr 27, 1988
PERIODONTAL PROBE - AUTOPROBE
K880209 · EIL
Dentsply Intl.
Dental · 103d
Cleared Apr 27, 1988
DACOMED CYSTOMETER
K880391 · EXQ
Dacomed Corp.
Gastroenterology & Urology · 89d
Cleared Apr 27, 1988
ENZYGNOST(R) TAT REAGENTS
K880700 · JBQ
Behring Diagnostics, Inc.
Hematology · 65d
Cleared Apr 27, 1988
LX-100 SLIDE STAINER
K880745 · KPA
Innovative Medical Systems, Inc.
Hematology · 63d
Cleared Apr 27, 1988
UMBILICAL CORD CLAMP
K880753 · HFW
I M, Inc.
Obstetrics & Gynecology · 62d
Cleared Apr 27, 1988
LIFEGUARD BACTERIAL AND VIRAL FILTER
K880958 · CAH
Lifeguard Medical Products, Inc.
General Hospital · 51d
Cleared Apr 27, 1988
7.5 MHZ ENDORECTAL PROBE
K881028 · IYO
Philips Ultrasound, Inc.
Radiology · 48d
Cleared Apr 27, 1988
VAPOR-PHASE HEATED WIRE CONTROLLER
K881137 · BZE
Advanced Research Technologies, Inc.
Anesthesiology · 42d