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
137401–137424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1987
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+
K873776 · FRN
Y
General Hospital · 78d
Cleared Dec 03, 1987
MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE
K873921 · DTB
Intermedics, Inc.
Cardiovascular · 69d
Cleared Dec 03, 1987
'CATCH-IT' OR FECAL CONTAINMENT DEVICE
K873929 · EXB
Midwest Medical Co.
Gastroenterology & Urology · 69d
Cleared Dec 03, 1987
PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
K874045 · NWU
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 59d
Cleared Dec 03, 1987
STACHROM VIII:C TEST KIT
K874097 · GGP
American Bioproducts Co.
Hematology · 56d
Cleared Dec 03, 1987
OHMEDA BIOX 3760 PULSE OXIMETER
K874104 · DQA
Ohmeda Medical
Anesthesiology · 56d
Cleared Dec 03, 1987
CUMEVAC
K874410 · FFD
Cumes-Honikman Partnership
Gastroenterology & Urology · 36d
Cleared Dec 03, 1987
PHARMASEAL RUBBER URETHRAL CATHETER
K874517 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 31d
Cleared Dec 02, 1987
BEAR VH-820 HUMIDIFIER
K873634 · BTT
Bear Medical Systems, Inc.
Anesthesiology · 84d
Cleared Dec 02, 1987
SPIRO ANALYZER ST-300
K873817 · BZG
Futuremed Div. of Future Impex Corp.
Anesthesiology · 72d
Cleared Dec 02, 1987
COMPANION MINI OXYGEN SAVER
K873901 · NFB
Puritan Bennett Corp.
Anesthesiology · 69d
Cleared Dec 02, 1987
PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15
K873911 · HIT
Richmond Products, Inc.
Ophthalmic · 68d
Cleared Dec 02, 1987
COLOR BOOK ILLUMINATOR STAND
K873913 · HJD
Richmond Products, Inc.
Ophthalmic · 68d
Cleared Dec 02, 1987
CAPTAIN POWER SUNGLASSES STYLES: #1020 #1021
K873983 · HQY
Arcotoys, Inc.
Ophthalmic · 63d
Cleared Dec 02, 1987
CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER
K874276 · FZW
Cox-Uphuff Intl.
General & Plastic Surgery · 43d
Cleared Dec 02, 1987
MAXIMUM CONTROL GOWN
K874318 · FYC
Ulti-Med Intl., Inc.
General Hospital · 43d
Cleared Dec 02, 1987
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
K874426 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Dec 02, 1987
AUTO SUTURE PURSE STRING APPLIER*
K874428 · GDJ
United States Surgical, A Division of...
General & Plastic Surgery · 35d
Cleared Dec 02, 1987
MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER
K874503 · HWM
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 30d
Cleared Dec 02, 1987
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
K874572 · DBF
Nichols Institute Diagnostics
Immunology · 27d
Cleared Dec 02, 1987
ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE
K874585 · DWO
Angiomed U.S., Inc.
General & Plastic Surgery · 23d
Cleared Dec 02, 1987
PERFORATED SOAKING TUBE
K874596 · GBQ
Specialty Medical Products Co.
General & Plastic Surgery · 23d
Cleared Dec 02, 1987
TECNOL FLUID SHIELD SURGICAL MASK
K874608 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 23d
Cleared Dec 02, 1987
NSN #6515-00-333-2400 ADSON DRESSING FORCEPS
K874634 · GEN
I-Tech Industries, Inc.
General & Plastic Surgery · 22d