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
136801–136824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1988
SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED
K874939 · DXQ
Kirschner Medical Corp.
Cardiovascular · 62d
Cleared Feb 02, 1988
FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS
K874962 · HAO
Solway, Inc.
Neurology · 62d
Cleared Feb 02, 1988
SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE
K875104 · LLO
Laserguide
Anesthesiology · 46d
Cleared Feb 02, 1988
WAKO(TM) UIBC
K875176 · JQF
Wako Chemicals USA, Inc.
Chemistry · 47d
Cleared Feb 02, 1988
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
K875206 · CFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Feb 02, 1988
ALKALINE PHOSPHATASE CAT. # 306-22, 306-23
K875210 · CJE
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Feb 02, 1988
V-TREND BETA-HCG DRY-SPOT TEST
K875262 · JHJ
Texas Immunology, Inc.
Chemistry · 42d
Cleared Feb 02, 1988
BIOTROL CALIBRANT LEVEL 1
K875288 · JIX
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Feb 02, 1988
BIOTROL CALIBRANT LEVEL 3
K875318 · JIX
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Feb 01, 1988
KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265
K870815 · GWQ
Kontron Instruments, Inc.
Neurology · 335d
Cleared Feb 01, 1988
ELECTROSTIM I.F.
K873566 · LIH
Promatek Industries, Ltd.
Neurology · 152d
Cleared Feb 01, 1988
ACID PHOSPHATASE (KINETIC) CAT. # 320-06
K875209 · CKB
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 45d
Cleared Feb 01, 1988
BIOTROL URIC ACID ENZYMATIQUE UV H.P.
K875320 · CDO
Biotrol, USA, Inc.
Chemistry · 34d
Cleared Feb 01, 1988
EDEC 60 R/F
K875341 · IZO
Electromed Intl., Ltd.
Radiology · 33d
Cleared Jan 29, 1988
SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE
K873533 · DSI
Medical Electronics Laboratories, Inc.
Cardiovascular · 150d
Cleared Jan 29, 1988
VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM
K873546 · DWJ
Reimers Engineering, Inc.
Cardiovascular · 150d
Cleared Jan 29, 1988
NAMIC HAWKINS UNIVERSAL DRAINAGE SET
K873954 · FGE
North American Instrument Corp.
Gastroenterology & Urology · 123d
Cleared Jan 29, 1988
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K874020 · KPF
Abbott Laboratories
Gastroenterology & Urology · 119d
Cleared Jan 29, 1988
ANGIO WASTE FLUIDS DUMP BAG
K874037 · DQO
Procedure Products, Inc.
Cardiovascular · 116d
Cleared Jan 29, 1988
ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD
K874183 · DTB
Daig Corp.
Cardiovascular · 108d
Cleared Jan 29, 1988
MODEL DMC-75 MINI-CATHETER SET
K874307 · FPA
Life-Tech Intl., Inc.
General Hospital · 101d
Cleared Jan 29, 1988
HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
K874514 · FLL
Mallinckrodt Critical Care
General Hospital · 88d
Cleared Jan 29, 1988
MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR
K874519 · BZW
Mon-A-Therm, Inc.
Anesthesiology · 88d
Cleared Jan 29, 1988
MODIFIED MYOCARDIAL TEMPERATURE SENSOR
K874522 · KRB
Mon-A-Therm, Inc.
Cardiovascular · 88d