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
143881–143904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1986
DINAMAP VITAL SIGNS MONITOR MODEL 8100
K854434 · DXN
Critikon Company, LLC
Cardiovascular · 192d
Cleared May 16, 1986
PULSE OXIMETER
K855027 · DQA
Physio-Control Corp.
Anesthesiology · 151d
Cleared May 16, 1986
MODEL 535 NEO-TRAK RECORDER
K855045 · DSF
Ge Medical Systems Information...
Cardiovascular · 150d
Cleared May 16, 1986
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K860572 · LCP
Pointe Scientific, Inc.,
Hematology · 91d
Cleared May 16, 1986
EZ DETECT, 5 MINUTE STREP-A COLOR TEST
K860923 · GTZ
Self Care Systems, Inc.
Microbiology · 66d
Cleared May 16, 1986
CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)
K861198
Quali-Med, Inc.
General & Plastic Surgery · 46d
Cleared May 16, 1986
PROTEIN C CONTROL PLASMA
K861216 · GGP
American Bioproducts Co.
Hematology · 46d
Cleared May 16, 1986
ARTHROSCOPE W/CANNULATED OBTUR/DRILL BITS & WRENCH
K861268 · HRX
Orthopedic Systems, Inc.
Orthopedic · 46d
Cleared May 16, 1986
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM
K861359 · DPS
Hewlett-Packard Co.
Cardiovascular · 36d
Cleared May 16, 1986
MODIFIED UNISCEPT KB LABELING AMENDMENT
K861408 · JWY
Analytab Products, Inc.
Microbiology · 31d
Cleared May 16, 1986
DEMAND OXYGEN SAVER SYSTEM (D02S)
K861423 · BZQ
Applied Membrane Technology, Inc.
Anesthesiology · 30d
Cleared May 16, 1986
MIAMI-SUNNY
K861636 · FTC
Sunworld Corp.
General & Plastic Surgery · 17d
Cleared May 16, 1986
CORONA 3000 (DERMATOLOGIC ULTRAVIOLET LAMP)
K861705 · FTC
Vita-Tan Corp.
General & Plastic Surgery · 11d
Cleared May 16, 1986
A TENS (MODEL AI-86)
K861709 · GZJ
American Imex
Neurology · 11d
Cleared May 16, 1986
SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE
K861711 · GDT
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 11d
Cleared May 16, 1986
REGAN-LOWE AGAR
K861734 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 10d
Cleared May 15, 1986
SHORT RAGWEED ALLERGEN DISC
K854756 · DHB
Immuno Nuclear Corp.
Immunology · 169d
Cleared May 15, 1986
MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER
K860235 · ITX
Hoffrel Instruments, Inc.
Radiology · 113d
Cleared May 15, 1986
SM-RNP AUTOANTIBODY TEST SYSTEM
K860428 · LLL
Immuno Concepts, Inc.
Immunology · 100d
Cleared May 15, 1986
ONE TIME ENTERAL FEEDING BAG
K860818 · KNT
Acme United Corp.
Gastroenterology & Urology · 72d
Cleared May 15, 1986
ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER
K860863 · LQC
George Percy Mcgown
Gastroenterology & Urology · 69d
Cleared May 15, 1986
JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)
K860943 · KPL
Colon Therapeutics
Gastroenterology & Urology · 64d
Cleared May 15, 1986
DUTHOY STONE BASKET
K861469 · FFL
Lake Region Mfg., Inc.
Gastroenterology & Urology · 23d
Cleared May 15, 1986
BARD DOUBLE PIGTAIL URETERAL STENT
K861478 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 23d