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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
135121–135144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 1988
BABYROCKER
K881019 · FMS
Cinventa AB
General Hospital · 89d
Cleared Jun 07, 1988
PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER
K881099 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 84d
Cleared Jun 07, 1988
BILIRUBIN (DIRECT)
K881172 · CIG
Tech-Co, Inc.
Chemistry · 81d
Cleared Jun 07, 1988
ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)
K881173 · CIQ
Tech-Co, Inc.
Chemistry · 81d
Cleared Jun 07, 1988
DYNATECH SPD 2000, NUMBER 002-910-0000
K881195 · JQW
Dynatech Laboratories, Inc.
Chemistry · 78d
Cleared Jun 07, 1988
GENT-L-KARE VAGINAL IRRIGATION SET
K881216 · HED
Geneva Laboratories, Inc.
Obstetrics & Gynecology · 77d
Cleared Jun 07, 1988
BION HSV1-G OR HSV2-G TEST SYSTEM
K881261 · GQO
Bion Ent., Ltd.
Microbiology · 75d
Cleared Jun 07, 1988
DAHLBERG MODEL GP BODY AID
K881417 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 07, 1988
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY
K881617 · LSE
Granbio, Inc.
Microbiology · 53d
Cleared Jun 07, 1988
IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT
K881661 · EMA
Specialites Septodont
Dental · 53d
Cleared Jun 07, 1988
BUN (KINETIC)
K881677 · CDQ
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Jun 07, 1988
TERUMO SENSIBEAD EIA PROGESTERONE KIT
K881693 · JIS
Terumo Medical Corp.
Chemistry · 49d
Cleared Jun 07, 1988
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN
K881798 · CIG
Technicon Instruments Corp.
Chemistry · 41d
Cleared Jun 07, 1988
DRY COMFORT DISPOSABLE UNDERPAD
K881969 · KME
Health Tec, Inc.
General Hospital · 27d
Cleared Jun 06, 1988
DPX BONE DENSITOMETER
K873296 · KGI
Lunar Radiation Corp.
Radiology · 294d
Cleared Jun 06, 1988
EFFNER CAUTERY INSTRUMENTS
K875260 · HQP
Effner and Spreine Co.
Ophthalmic · 167d
Cleared Jun 06, 1988
WAKO(TM) IGG-HA DIRECT
K880784 · DEW
Wako Chemicals USA, Inc.
Immunology · 101d
Cleared Jun 06, 1988
ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY
K880982 · KPR
Orion Corporation Soredex
Radiology · 90d
Cleared Jun 06, 1988
SLT CONTACT LASER SYSTEM OCULOPLASTICS
K881134 · HQF
Surgical Laser Technologies, Inc.
Ophthalmic · 82d
Cleared Jun 06, 1988
IMMUNOGLOBULIN M TEST SYSTEM
K881828 · CFQ
The Binding Site, Ltd.
Immunology · 38d
Cleared Jun 06, 1988
NEW SIZES SUGITA CLIPS
K881911 · HCI
Downs Surgical , Ltd.
Neurology · 28d
Cleared Jun 06, 1988
SANO CLIP APPLIERS & REMOVERS
K881912 · HCI
Downs Surgical , Ltd.
Neurology · 28d
Cleared Jun 06, 1988
REUSABLE FIBEROPTIC LIGHTPIPE
K881926 · HQB
Advanced Surgical Products, Inc.
Ophthalmic · 28d
Cleared Jun 06, 1988
KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST
K881933 · JZO
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 27d