FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

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

5,198 results for "health"
4729–4752 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 02, 1988
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757 · DIF
Baxter Healthcare Corp
Toxicology · 76d
Cleared Feb 02, 1988
SARNS VISIFLOW AORTIC ARCH CANNULA
K874896 · DWF
3M Health Care, Sarns
Cardiovascular · 63d
Cleared Jan 29, 1988
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K874695 · DRT
Healthdyne, Inc.
Cardiovascular · 74d
Cleared Jan 29, 1988
CAPILLARY FLOW DIALYZERS
K874728 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 72d
Cleared Jan 21, 1988
STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY
K874438 · LEH
Baxter Healthcare Corp
Chemistry · 85d
Cleared Jan 11, 1988
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
K874876 · JWY
Baxter Healthcare Corp
Microbiology · 42d
Cleared Jan 06, 1988
AUTO SYRINGE MODEL AS20G INFUSION PUMP
K873746 · FRN
Baxter Healthcare Corp
General Hospital · 112d
Cleared Jan 05, 1988
PARAMAX URINE/CSF CALIBRATOR
K874587 · JIX
Baxter Healthcare Corp
Chemistry · 57d
Cleared Dec 17, 1987
AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE
K874879 · GDH
United States Surgical, A Division of...
General & Plastic Surgery · 38d
Cleared Dec 14, 1987
PARAMAX CALCIUM REAGENT
K873519 · CIC
Baxter Healthcare Corp
Chemistry · 104d
Cleared Dec 14, 1987
PARAMAX MAGNESIUM REAGENT
K873530 · JGJ
Baxter Healthcare Corp
Chemistry · 104d
Cleared Dec 14, 1987
PARAMAX ISE CHLORIDE CALIBRATOR
K873743 · JIT
Baxter Healthcare Corp
Chemistry · 89d
Cleared Dec 02, 1987
AUTO SUTURE PURSE STRING APPLIER*
K874428 · GDJ
United States Surgical, A Division of...
General & Plastic Surgery · 35d
Cleared Nov 23, 1987
PARAMAX PHOSPHORUS REAGENT
K873454 · CEO
Baxter Healthcare Corp
Chemistry · 87d
Cleared Nov 23, 1987
PARAMAX URIC ACID REAGENT
K873456 · KNK
Baxter Healthcare Corp
Chemistry · 87d
Cleared Nov 23, 1987
PARAMAX AMYLASE REAGENT
K873520 · CJA
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
PARAMAX CREATININE REAGENT
K873531 · CGX
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
PARAMAX UREA NITROGEN REAGENT
K873532 · CDQ
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
MODIFIED PARAMAX GLUCOSE REAGENT
K873936 · CFR
Baxter Healthcare Corp
Chemistry · 59d
Cleared Nov 13, 1987
UNIPORT MODELS SD-90, TD-60, TD-70 & TD-90
K873575 · LJT
Healthcare Technologies, Inc.
General Hospital · 80d
Cleared Nov 06, 1987
BONE MARROW COLLECTION KIT AND STAND
K871198 · LWE
Baxter Healthcare Corp
General Hospital · 227d
Cleared Nov 06, 1987
SARNS CARDIOPLEGIA/VENT CATHETERS
K873212 · DWF
3M Health Care, Sarns
Cardiovascular · 84d
Cleared Nov 06, 1987
SARNS WARMER, PART #164975 AND #164980
K873813 · DWC
3M Health Care, Sarns
Cardiovascular · 49d
Cleared Oct 23, 1987
LASER RESISTANT DRAPE
K873141 · KKX
Baxter Healthcare Corp
General Hospital · 74d