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
97441–97464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1996
0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER
K961208 · IYE
Ptw-New York Corp.
Radiology · 83d
Cleared Jun 17, 1996
AMO PHACOFLEX II INTERSECTION SYSTEM
K961242 · KYB
Allergan, Inc.
Ophthalmic · 77d
Cleared Jun 17, 1996
ACS FRT4 IMMUNOASSAY
K961510 · JJX
Ciba Corning Diagnostics Corp.
Chemistry · 59d
Cleared Jun 14, 1996
FIRST CHOICE GLUCOSE URINE TEST STRIPS
K953661 · JIL
Polymer Technology Intl.
Chemistry · 312d
Cleared Jun 14, 1996
FIRST CHOICE KETONES URINE TEST STRIPS
K953662 · JIN
Polymer Technology Intl.
Chemistry · 312d
Cleared Jun 14, 1996
CANDELA Q-SWITCHED ALEXANDRITE LASERS
K955662 · GEX
Candela Laser Corp.
General & Plastic Surgery · 185d
Cleared Jun 14, 1996
MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE
K960531 · GKZ
Dako Corp.
Hematology · 128d
Cleared Jun 14, 1996
5MM ENDOSCOPE
K960637 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 121d
Cleared Jun 14, 1996
COMPLEMENT CONTROL
K960874 · JJX
Wako Chemicals USA, Inc.
Immunology · 102d
Cleared Jun 14, 1996
HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24
K960934 · MLD
Hewlett-Packard Co.
Cardiovascular · 98d
Cleared Jun 14, 1996
AUTOMATED VITRECTOMY DEVICE
K961078 · HQE
Promex, Inc.
Ophthalmic · 88d
Cleared Jun 14, 1996
VISART
K961092 · LNH
Toshiba America Medical Systems, In.C
Radiology · 87d
Cleared Jun 14, 1996
ATI PLASMA PUMP (PP-04)
K961137 · FIR
Apheresis Technologies, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 14, 1996
POWERED LOW AIR LOSS MATTRESS SYSTEM
K961159 · FNM
Span-America Medical Systems, Inc.
General Hospital · 84d
Cleared Jun 14, 1996
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
K961354 · JJS
Radiometer America, Inc.
Chemistry · 67d
Cleared Jun 14, 1996
MULTICHECK
K961355 · JJS
Radiometer America, Inc.
Chemistry · 67d
Cleared Jun 14, 1996
MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE
K961435 · GKZ
Dako Corp.
Hematology · 60d
Cleared Jun 14, 1996
ELECSYS 2010 ANALYZER
K961481 · JJE
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Jun 14, 1996
FOUNDATION 9MM FORGED CEMENTED STEM
K961890 · JDI
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Jun 14, 1996
KARL STORZ REMORGIDA FORCEPS
K962030 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 21d
Cleared Jun 13, 1996
HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT
K933722 · CDT
Horizon Diagnostics, Inc.
Chemistry · 1046d
Cleared Jun 13, 1996
PLAMP, PLAMP PLATE, PLAMP WITH HOOK
K942032 · HRS
Hospital For Special Surgery
Orthopedic · 779d
Cleared Jun 13, 1996
BREATH-TAKER BREATH-ALERT
K953411 · BZH
Roxon - Universal Medical , Ltd.
Anesthesiology · 329d
Cleared Jun 13, 1996
THE IMS DPAP MASK, IMS MODEL NUMBER 82000
K953697 · BZD
Sleepnet Corporation
Anesthesiology · 310d