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
103009–103032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1995
KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES
K951395 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 42d
Cleared May 09, 1995
M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM
K951424 · EOX
M.E.R. Surgical Co.
Ear, Nose, Throat · 43d
Cleared May 09, 1995
KARL STORZ ENDOSCOPES, TELESCOPE HOLDERS
K951535 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 36d
Cleared May 09, 1995
NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR
K951641 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 49d
Cleared May 09, 1995
DYNAREX GAUZE SPONGE
K951660 · EFQ
Dynarex Corp.
General & Plastic Surgery · 29d
Cleared May 09, 1995
FMS ARTHRO-CUTTER
K951701 · HNX
Future Medical Systems, Inc.
Ophthalmic · 27d
Cleared May 08, 1995
WAHL FRESH FACE
K944909 · IRO
Wahl Clipper Corp.
Physical Medicine · 215d
Cleared May 08, 1995
SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE
K945541 · HKY
Rudolf Riester GmbH & Co. KG
Ophthalmic · 179d
Cleared May 08, 1995
GLUCOSE (HK) REAGENT (PROCEDURE NO.16)
K945908 · CFR
Sigma Diagnostics, Inc.
Chemistry · 157d
Cleared May 08, 1995
OSTEOMARK(R)
K945946 · JMM
Ostex Intl., Inc.
Chemistry · 154d
Cleared May 08, 1995
DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
K946354 · JMO
Data Medical Associates, Inc.
Chemistry · 129d
Cleared May 08, 1995
ATRAUMAX SURGICAL CLAMP
K950492 · DXC
Applied Medical Resources
Cardiovascular · 91d
Cleared May 08, 1995
SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)
K950958 · JJE
Beckman Instruments, Inc.
Chemistry · 82d
Cleared May 08, 1995
CEDIA DAU AMPHETAMINES ASSAY
K951154 · DKZ
Microgenics Corp.
Toxicology · 55d
Cleared May 08, 1995
AURAFLEX PROGESTERONE 150TEST PACK
K951630 · JLS
Organon Teknika Corp.
Chemistry · 31d
Cleared May 06, 1995
ARTHROGRAM TRAY
K950683 · JAA
Surgical Technologies, Inc.
Radiology · 81d
Cleared May 05, 1995
VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0
K926449 · IYE
Varian Assoc., Inc.
Radiology · 862d
Cleared May 05, 1995
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM FAMILY
K931490 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 771d
Cleared May 05, 1995
AMBU PORTABLE SUCTION UNIT
K932031 · BTA
Ambu, Inc.
General & Plastic Surgery · 738d
Cleared May 05, 1995
EBNA IGG ELISA TEST SYSTEM
K932742 · LLM
Zeus Scientific, Inc.
Microbiology · 696d
Cleared May 05, 1995
THE ULTRA
K935755 · KCT
Medical Device Systems, Inc.
General Hospital · 525d
Cleared May 05, 1995
INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING
K941608 · DZE
Calcitek, Inc.
Dental · 399d
Cleared May 05, 1995
INSTASPOT
K942504 · LLZ
Fidelity Medical, Inc.
Radiology · 344d
Cleared May 05, 1995
CMI VELVET TOUCH VACUUM EXTRACTOR
K942725 · HDB
Columbia Medical & Surgical, Inc.
Obstetrics & Gynecology · 330d