FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
108649–108672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1994
CORPAK ENTERAL PUMP
K932847 · FRN
Corpak Co.
General Hospital · 372d
Cleared Jun 17, 1994
SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD
K933748 · FXX
Bam Corp., Ltd.
General Hospital · 323d
Cleared Jun 17, 1994
RPPI STERILIZATION BAGS
K934252 · KCT
Royal Precision Plastics, Inc.
General Hospital · 290d
Cleared Jun 17, 1994
SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS
K934817 · FNM
Surgical Design Corp.
General Hospital · 255d
Cleared Jun 17, 1994
STRYKER 5000
K935949 · FNM
Stryker Medical
General Hospital · 186d
Cleared Jun 17, 1994
PLATINUM PLUS GUIDEWIRE
K935997 · DQX
Boston Scientific Corp
Cardiovascular · 184d
Cleared Jun 17, 1994
MODEL 2000 OPHTHALMIC SURGICAL SYSTEM
K940084 · HQC
Medical Technical Products
Ophthalmic · 161d
Cleared Jun 17, 1994
SPECTACLE FRAMES (V.I.P. INT'L)
K940733 · HQZ
Continental Optical Imports
Ophthalmic · 162d
Cleared Jun 17, 1994
SUNGLASSES
K940923 · HQY
Gbs Corp.
Ophthalmic · 109d
Cleared Jun 17, 1994
SUNGLASSES
K941061 · HQY
Kingmart Trading Co., Ltd.
Ophthalmic · 101d
Cleared Jun 17, 1994
MEDSAVER SYRINGE
K941095 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 100d
Cleared Jun 17, 1994
DIAGNOSTIC SLEEVE, REDUCER SLEEVE
K941208 · HET
New Eder Corp.
Obstetrics & Gynecology · 95d
Cleared Jun 17, 1994
SPECTACLE FRAMES
K941211 · HQZ
H & M Optical (U.S.A.) , Ltd.
Ophthalmic · 99d
Cleared Jun 17, 1994
MINI-UB ENDOSCOPES
K941230 · ODF
Candela Laser Corp.
Gastroenterology & Urology · 94d
Cleared Jun 17, 1994
SHARP II HELIX HEARING AID
K941295 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 17, 1994
SPECTACLE FRAMES, READING GLASSES
K941463 · HQZ
Well Arts Optical Factory , Ltd.
Ophthalmic · 81d
Cleared Jun 17, 1994
OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM
K941919 · FET
Oktas
Gastroenterology & Urology · 58d
Cleared Jun 17, 1994
PHILIPS 61 SERIES
K942164 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 44d
Cleared Jun 17, 1994
OPTIMA WITH DELTA AMP
K942213 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 42d
Cleared Jun 17, 1994
AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)
K942236 · LRB
Audina Hearing Instrument
Ear, Nose, Throat · 39d
Cleared Jun 16, 1994
QUICKANCHOR II
K931253 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 461d
Cleared Jun 16, 1994
ACUFEX SURETAC
K931519 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 447d
Cleared Jun 16, 1994
ACE PELVIC STABILIZER
K933968 · JEC
Ace Medical Co.
Orthopedic · 304d
Cleared Jun 16, 1994
DSL ESTRONE (DSL 8700)
K935013 · CGF
Diagnostic Systems Laboratories, Inc.
Chemistry · 239d