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
104329–104352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1995
DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B
K944884 · ISA
Kolvin Industries , Ltd.
Physical Medicine · 134d
Cleared Feb 14, 1995
DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000,...
K944885 · ISA
Kolvin Industries , Ltd.
Physical Medicine · 134d
Cleared Feb 14, 1995
NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM
K945516 · LZO
Intermedics Orthopedics
Orthopedic · 97d
Cleared Feb 14, 1995
VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE
K945738 · HMT
Visitec Co.
General Hospital · 83d
Cleared Feb 14, 1995
STORZ PHACOEMULSIFICATION NEEDLES
K946176 · HQC
Storz Instrument Co.
Ophthalmic · 57d
Cleared Feb 14, 1995
ELASTYREN(R) PATIENT EXAMINATION GLOVES
K946291 · LZA
Eci Medical Technologies, Inc.
General Hospital · 49d
Cleared Feb 14, 1995
RELAXY-WONDER KNOCK
K950320 · ISA
Kinsei Shiatsu, Inc.
Physical Medicine · 19d
Cleared Feb 14, 1995
SHAPE UP MOMI ROLLER
K950321 · ISA
Kinsei Shiatsu, Inc.
Physical Medicine · 19d
Cleared Feb 14, 1995
RELAXY-THE WONDER HAND
K950322 · ISA
Kinsei Shiatsu, Inc.
Physical Medicine · 19d
Cleared Feb 13, 1995
SPS 1550 SINGLE NEEDLE PATIENT SYSTEM
K922757 · FKP
Baxter Healthcare Corp
Gastroenterology & Urology · 979d
Cleared Feb 13, 1995
SONAMET BODY COMPOSITION ANALYZER
K924972 · OAC
Life Measurement Instruments, Inc.
Obstetrics & Gynecology · 866d
Cleared Feb 13, 1995
ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K926354 · DZE
Innova Corp.
Dental · 784d
Cleared Feb 13, 1995
MCA 200 HEMPDIALYZER
K926372 · FJI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 783d
Cleared Feb 13, 1995
ALTRA FLUX 200 HEMODIALYZER
K926373 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 783d
Cleared Feb 13, 1995
ALTRA NOVA 200 HEMODAILYZER
K926379 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 783d
Cleared Feb 13, 1995
GASTRIC, CATHETER, IRRIGATION & ASPIRATION
K933596 · BSS
Polamedco, Inc.
Gastroenterology & Urology · 567d
Cleared Feb 13, 1995
GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA
K935844 · FCG
Medi-Globe Corp.
Gastroenterology & Urology · 432d
Cleared Feb 13, 1995
IUMC ENDOMETRIAL SAMPLER
K941298 · HFE
Cook Ob/Gyn
Obstetrics & Gynecology · 333d
Cleared Feb 13, 1995
DENT-O-CRYL ORTHODONTIC ACRYLIC
K942667 · KMY
Dentauraum, Inc.
Dental · 252d
Cleared Feb 13, 1995
DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
K943397 · CJM
Diagnostic Systems Laboratories, Inc.
Chemistry · 214d
Cleared Feb 13, 1995
NEUTRALON LP BROWN LATEX SURGICAL GLOVES
K943674 · KGO
Maxxim Medical
General Hospital · 202d
Cleared Feb 13, 1995
MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GLOVES
K945157 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 115d
Cleared Feb 13, 1995
MICRO-TOUCH LP LATEX SURGICAL GLOVES
K945158 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 115d
Cleared Feb 13, 1995
DJ MEDICAL PNEUMATIC TOURNIQUET
K945167 · KCY
Dj Medical, Inc.
General & Plastic Surgery · 144d