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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
113689–113712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1993
OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER
K925935 · JJQ
Olympus Corp.
Chemistry · 154d
Cleared Apr 22, 1993
LD-1 CONTROL-LEVEL 1 & 2
K930874 · JJX
Cala Diagnostics
Chemistry · 62d
Cleared Apr 21, 1993
ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000
K921168 · KZD
Allen Medical Systems, Inc.
General Hospital · 407d
Cleared Apr 21, 1993
SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM
K922221 · LOS
Del Mar Avionics
Cardiovascular · 344d
Cleared Apr 21, 1993
PHARMACIA DELTEC WINGED INFUSION SET
K923019 · LJT
Pharmacia Deltec, Inc.
General Hospital · 302d
Cleared Apr 21, 1993
DISPOSABLE HOT BIOPSY FORCEPS
K923470 · KGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 281d
Cleared Apr 21, 1993
INTERLINK UNIVERSAL VIAL ADAPTER
K924064 · LHI
Baxter Healthcare Corp
General Hospital · 252d
Cleared Apr 21, 1993
OJEMANN CORTICAL STIMULATOR
K924226 · GYC
Radionics, Inc.
Neurology · 243d
Cleared Apr 21, 1993
BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT
K924671 · BTM
Engineered Medical Systems
Anesthesiology · 217d
Cleared Apr 21, 1993
ISOPORE(TM) TAPE, MODIFICATION
K925384 · KGX
Lectec Corp.
General & Plastic Surgery · 177d
Cleared Apr 21, 1993
EMS BIOPSY INSTRUMENT
K930083 · KNW
Engineered Medical Systems
Gastroenterology & Urology · 104d
Cleared Apr 21, 1993
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
K930166 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 98d
Cleared Apr 21, 1993
K-LOK CATHETER SECUREMENT DEVICE
K930225 · KMK
K-Lok, Inc.
General Hospital · 96d
Cleared Apr 21, 1993
PROSPEC T GIARDIA MICROTITER ASSAY
K930451 · MHI
Alexon, Inc.
Microbiology · 84d
Cleared Apr 21, 1993
NYLEX CATHETERS
K930479 · DQO
Cordis Corp.
Cardiovascular · 82d
Cleared Apr 21, 1993
RADIAS AUTOMATED IMMUNOASSAY SYSTEM
K930898 · JJI
Bio-Rad
Chemistry · 58d
Cleared Apr 21, 1993
PROCHECK(TM) BLIND PERFORMANCE SPECIMENS
K931105 · DIF
Dynagen, Inc.
Toxicology · 49d
Cleared Apr 20, 1993
ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM
K913566 · GEX
Alfred O. Bonati, M.D.
General & Plastic Surgery · 620d
Cleared Apr 20, 1993
ONAT BALLOONED NASOGASTRIC TUBE
K920262 · KNT
Macdonald Medical Devices, Inc.
Gastroenterology & Urology · 455d
Cleared Apr 20, 1993
MARLOW LAPAROSCOPIC GRASPING FORCEP
K920611 · GCJ
Marlo Surgical Technology
General & Plastic Surgery · 434d
Cleared Apr 20, 1993
MACVIEW
K920851 · LLZ
Dimensional Medicine, Inc.
Radiology · 440d
Cleared Apr 20, 1993
BURNSHIELD FIRE BLANKET
K921470 · FPY
Levtrade Intl. (Pty) , Ltd.
General & Plastic Surgery · 389d
Cleared Apr 20, 1993
BURNSHIELD TRAUMA DRESSING
K921471 · FPY
Levtrade Intl. (Pty) , Ltd.
General & Plastic Surgery · 389d
Cleared Apr 20, 1993
INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET
K921899 · FPA
Baxter Healthcare Corp
General Hospital · 363d