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
134209–134232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1988
HISTO-CHECK SLIDES
K883208 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 27d
Cleared Aug 25, 1988
RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
K883333 · JTL
Immuno-Mycologics, Inc.
Microbiology · 16d
Cleared Aug 25, 1988
SURGICAL CONNECTING TUBES
K883473 · GAZ
Westmark, Sterile Packing Systems,...
General Hospital · 9d
Cleared Aug 25, 1988
OWREN'S VERONAL BUFFER
K883484 · JPA
Helena Laboratories
Hematology · 9d
Cleared Aug 24, 1988
BREATHING CIRCUIT W/HEATED WIRE
K880769 · BZE
Dryden Corp.
Anesthesiology · 177d
Cleared Aug 24, 1988
GAMBRO MULTIPURPOSE SYSTEM MPS-10
K881270 · FII
Gambro, Inc.
Gastroenterology & Urology · 153d
Cleared Aug 24, 1988
VIGGO INSUFLON
K881767 · FOZ
Ohmeda Medical
General Hospital · 121d
Cleared Aug 24, 1988
MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K881834 · IYO
Ge Medical Systems Information...
Radiology · 117d
Cleared Aug 24, 1988
522 INTELLIGENT PUMP
K882159 · FRN
Kendall Mcgaw Laboratories, Inc.
General Hospital · 93d
Cleared Aug 24, 1988
ACUMED 9000 ETCO(2) MONITOR
K882661 · CCK
Acumed Technologies, Inc.
Anesthesiology · 57d
Cleared Aug 24, 1988
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K882743 · CCL
Ohmeda Medical
Anesthesiology · 54d
Cleared Aug 24, 1988
SUNGLASSES, NON-PRESCRIPTION
K882769 · HQY
Spotlight Industries, Inc.
Ophthalmic · 49d
Cleared Aug 24, 1988
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
K883114 · JXG
Pmt Corp.
Neurology · 30d
Cleared Aug 24, 1988
OPTICAL OR EYEGLASS FRAME
K883226 · HQZ
Unique Optic , Ltd.
Ophthalmic · 23d
Cleared Aug 24, 1988
GENESIS II TRANSCRANIAL PROBE
K883238 · IYO
Biosound, Inc.
Radiology · 23d
Cleared Aug 24, 1988
MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
K883480 · FCT
Site Microsurgical Systems, Inc.
Ophthalmic · 8d
Cleared Aug 23, 1988
GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)
K873121 · LMD
General Electric Co.
Radiology · 378d
Cleared Aug 23, 1988
MD STRIPS BG
K875049 · CGA
Amatech International, Inc.
Chemistry · 258d
Cleared Aug 23, 1988
BD MICROFINE IV PEN INJECTOR
K881775 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 119d
Cleared Aug 23, 1988
ENDO-ICE
K881826 · EAT
The Hygenic Corp.
Dental · 116d
Cleared Aug 23, 1988
AMISCO U-100 INSULIN SYRINGE
K882114 · FMF
American Intl. Medical Supply Co.
General Hospital · 97d
Cleared Aug 23, 1988
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
K882766 · DLG
Em Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Aug 23, 1988
LASER MIXTURE
K882942 · GEX
Swisco, Inc.
General & Plastic Surgery · 47d
Cleared Aug 23, 1988
MASSAGE MACHINE (CAT. EM-01 ULE 111756)
K883064 · ISA
Emrad, Ltd.
Physical Medicine · 34d